Total 10 Director/C-Level Quality Assurance / Control job vacancies in US - California - South San Francisco

Package Description: At Avery Healthcare we believe in caring for those who care for our residents; We recognise and celebrate our hard-working colleagues, supporting your career development, offer a variety of apprenticeships, and provide you with access to a range of leisure and retail discounts. We are now seeking a compassionate, experienced and dedicated individual to join our friendly, award-winning team as an Associate Director of Quality based in our Central & South West Division. About The Role The role of Associate Director of Quality offers a fantastic opportunity within Avery Healthcare to ensure the exceptional standards of care delivery and quality services for our residents, relatives, and colleagues. Reporting to the Director of Quality and working with the Operational teams you will develop a culture that values the highest standards of care, safety, quality, and clinical risk. Leading by example, you will provide Leadership and take responsibility for ensuring robust quality assurance systems and processes, ensuring group quality indicators and regulatory requirements are fully satisfied and therefore ensuring that safe, quality care is delivered to residents. Our people are invaluable to us and for the future success of the business, you will inspire, coach, and develop a team of direct reports to take full accountability for ongoing development. Working with senior colleagues to drive continuous improvement, you will lead change and challenge conventional approaches, to create a learning organisation, offering expert advice on regulatory requirements, new services, and projects. Supporting the Director of Quality, you will provide professional nursing leadership and advice, supporting with any learning required. The health and wellbeing of everyone in our organisation is of the upmost importance to us so taking on the role of Infection Prevention Control lead, you will ensure that all policies are fit for purpose and up to date. This rewarding role includes an attractive salary package, including performance incentives, travel expenses and benefits. About You You will lead by example, driving our vision to offer exceptional care and experience whilst establishing ourselves as the preferred choice for residents and employees, creating meaningful lives together. You will live our values of caring, supportive, honest, respectful, and accountable in all that you do. To be successful in your application, you must: Be a 1st level Registered Nurse (nursing home) with current NMC number Have a minimum of 5 years experience in a Care & Quality role and be able to evidence experience of change management and impact Have proven experience in a leadership role, having managed a team successfully to deliver objectives Have a good knowledge of the regulatory framework Have the knowledge and understanding to analyse and interpret data to identify emerging risks, themes and trends and work with operational teams to identify practicable solutions Have the personal qualities to work with others, influence, negotiate and develop strong working relationships. Please note this role will require: Proof of eligibility to work in the UK A clear and enhanced DBS Disclosure check, the cost of which will be met by Avery

Package Description: At Avery Healthcare we believe in caring for those who care for our residents; We recognise and celebrate our hard-working colleagues, supporting your career development, offer a variety of apprenticeships, and provide you with access to a range of leisure and retail discounts. We are now seeking a compassionate, experienced and dedicated individual to join our friendly, award-winning team as an Associate Director of Quality based in our Central & South West Division. About The Role The role of Associate Director of Quality offers a fantastic opportunity within Avery Healthcare to ensure the exceptional standards of care delivery and quality services for our residents, relatives, and colleagues. Reporting to the Director of Quality and working with the Operational teams you will develop a culture that values the highest standards of care, safety, quality, and clinical risk. Leading by example, you will provide Leadership and take responsibility for ensuring robust quality assurance systems and processes, ensuring group quality indicators and regulatory requirements are fully satisfied and therefore ensuring that safe, quality care is delivered to residents. Our people are invaluable to us and for the future success of the business, you will inspire, coach, and develop a team of direct reports to take full accountability for ongoing development. Working with senior colleagues to drive continuous improvement, you will lead change and challenge conventional approaches, to create a learning organisation, offering expert advice on regulatory requirements, new services, and projects. Supporting the Director of Quality, you will provide professional nursing leadership and advice, supporting with any learning required. The health and wellbeing of everyone in our organisation is of the upmost importance to us so taking on the role of Infection Prevention Control lead, you will ensure that all policies are fit for purpose and up to date. This rewarding role includes an attractive salary package, including performance incentives, travel expenses and benefits. About You You will lead by example, driving our vision to offer exceptional care and experience whilst establishing ourselves as the preferred choice for residents and employees, creating meaningful lives together. You will live our values of caring, supportive, honest, respectful, and accountable in all that you do. To be successful in your application, you must: Be a 1st level Registered Nurse (nursing home) with current NMC number Have a minimum of 5 years experience in a Care & Quality role and be able to evidence experience of change management and impact Have proven experience in a leadership role, having managed a team successfully to deliver objectives Have a good knowledge of the regulatory framework Have the knowledge and understanding to analyse and interpret data to identify emerging risks, themes and trends and work with operational teams to identify practicable solutions Have the personal qualities to work with others, influence, negotiate and develop strong working relationships. Please note this role will require: Proof of eligibility to work in the UK A clear and enhanced DBS Disclosure check, the cost of which will be met by Avery

Job Description:

The Associate Director of Gift Compliance (“the AD”) contributes to Brown’s Advancement efforts by enabling and guiding fundraising staff through the process of developing, processing, and finalizing donor gift documentation. As a subject matter expert and service provider, the AD prioritizes instruction and efficient service for both staff and donors. Knowledge and application of federal laws, state regulations, and University policies is essential and the AD seeks to reflect these appropriately in written gift documentation. Interacting with Divisional and University leadership to put forward key fundraising milestones for Corporation approval is a recurring and vital part of the AD’s role. They also manage the team responsible for gift documentation services and in that capacity provide regular, routine training opportunities to promote broad knowledge and understanding amongst fundraising staff. In support of these efforts, the AD leverages their technical knowledge, data skills, and cross-team collaboration to continuously drive systematic process improvements resulting in an operation that is modern, efficient, and regarded as an organizational strength.

Brown University is committed to advancing diversity, inclusion, and equity and an Affirmative Action/Equal Opportunity Employer.

Education and Experience

• Bachelor’s degree required.

• Minimum of 5 years of development or related experience, in fields such as non-profits, fundraising, higher education, legal or technical writing

• Minimum of 2 years of supervisory or management experience

Required Qualifications

• Collaborative mindset and relationship-building skills

• Excellent written and oral communication skills, including copy-editing and proofreading

• Strong attention to detail and how the big picture is affected

• Excellent organization and management skills

• Strong analytical skills including demonstrated ability to interpret data and apply it to business decisions

• Basic data management and manipulation skills

• Comfortable learning new technologies coupled with the ability to self-learn

• Proficient knowledge of the MS Office Suite (Word, Excel, PowerPoint) and CRM systems

Job Competencies

• Demonstrated commitment to diversity and inclusion as well as an understanding of the contributions a diverse workforce brings to the workplace. 

• Growth mindset and leadership ability

• Diplomacy, poise, and discretion in dealing with executives and high-level donors

• Creative problem-solving within legal, policy, and political constraints

• Work independently and manage highly complex processes for a high-quality end product  

• Communicate effectively and professionally

• Work well under deadlines

• Collaborate in a team environment

Applicants are asked to submit a cover letter and resume with their application. All offers of employment are contingent upon a completed criminal background check and education verification satisfactory to Brown. 

Recruiting Start Date:

2024-02-20

Job Posting Title:

Associate Director, Gift Compliance

Department:

Advancement

Grade:

Grade 11

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

37.5

Position Work Location:

Hybrid Eligible

Submission Guidelines:

Please note that in order to be considered an applicant for any staff position at Brown University you must submit an application form for each position for which you believe you are qualified. Applications are not kept on file for future positions. Please include a cover letter and resume with each position application.

Still Have Questions?

If you have any questions you may contact employment@brown.edu.

EEO Statement:

Brown University is an E-Verify Employer.

As an EEO/AA employer, Brown University provides equal opportunity and prohibits discrimination, harassment and retaliation based upon a person’s race, color, religion, sex, age, national or ethnic origin, disability, veteran status, sexual orientation, gender identity, gender expression, or any other characteristic protected under applicable law, and caste, which is protected by our University policies.

24WD75377

Position Overview

In this role, you will implement strategies and operational improvements for the Volume businesses of Global License Compliance (GLC). Your responsibilities will include coaching the GLC sales personnel, managing third-party organizations, and ensuring the efficient operation of the North American business.

Reporting to the Senior Director of GLC, AMER, you will also develop business processes and strategies to exceed Autodesk GLC's key objectives for its North American Territory Sales. Working collaboratively with the executive staff and key internal stakeholders, you will drive policies and programs in line with the organization's strategic and operational priorities.

Responsbilities:

• Monitor the policies, practices and processes of GLC North America to determine efficiency and effectiveness. Recommend improvements and develops strategies to achieve and deliver improved results. Implement and follow standards as defined by Corporate and Division senior management; escalate exceptions or questionable practices to direct manager or senior management staff. This may include working with various data support teams, legal, PPL, and Corporate Compliance.
• Regularly interact with executives and/or major customers. Interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization.
• Manage and lead a team of top accomplished License compliance sales professionals to exceed assigned quotas, ensuring team efficiency and revenue goals are met. Responsible for the hiring, team effectiveness, culture, performance management and skill development of this team.
• Deliver timely and accurate forecasting of the business, within 2% variance, and pipeline management.
• Manage and develop resources (including consultants, vendors and remote workers, which may be in different time zones). This includes selection, mentoring/coaching, performance management and assessment, and rewards and recognition within own team.
• Work on complex issues where analysis of situations or data requires an in-depth knowledge of Autodesk, its licensing models, and industry best practices. Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensure budgets and schedules meet corporate and divisional requirements.
• Lead or sponsor cross functional or intra-divisional projects for Global License Compliance North America, especially projects related to streamlining and/or improving processes and systems.
• Lead the way in working collaboratively with Territory sales teams on account planning activities to ensure the best customer experiences.
• Manage sales KPIs, pipeline and activity metrics (all leading indicators) of team to ensure these are tracking towards achievement of revenue goals, while ensuring that a balance of sales and enforcement activity is maintained.
• Strategically monitor and review long term goals of the program and ensure campaigns are executed within budget and that License Compliance revenue targets are met.
• May make presentations to existing and prospective customers about the benefits of Autodesk software and engage in final stage negotiation with C level customers and be a point of escalation.
• Manage both Direct and Indirect sales motions.
• Manage a complex volume business that may include highly technical lead sources; responsible for prioritizing various lead programs for the team to maximize effectiveness of the business.
• Collaborates on best practices and drives License Compliance strategies with other geographies and functional groups.

Minimum Qualifications

• 10+ years of relevant experience in technical software or SAAS/PAAS sales; 5+ sales leadership experience with track record of creating high-performing teams.
• Sales experience includes track record of success in difficult negotiations with C-level, handling accounts in the enterprise segment, and conflict resolution.
• Experience in effectively managing a complex, volume-based and digital business and comfortable interfacing with stakeholders at all seniority levels.
• Familiarity with technology, licensing models, and business trends in Autodesk target industries.

Preferred Qualifications:

• Experience or knowledge in Cyber security practices or License Compliance industry
• Experience selling in value-based models
• Ability to build relationships at multiple levels
• Self-motivated with the ability to adapt to changing priorities and business initiative

About Autodesk

Welcome to Autodesk! Amazing things are created every day with our software – from the greenest buildings and cleanest cars to the smartest factories and biggest hit movies. We help innovators turn their ideas into reality, transforming not only how things are made, but what can be made.

 

We take great pride in our culture here at Autodesk – our Culture Code is at the core of everything we do. Our values and ways of working help our people thrive and realize their potential, which leads to even better outcomes for our customers.

 

When you’re an Autodesker, you can be your whole, authentic self and do meaningful work that helps build a better future for all. Ready to shape the world and your future? Join us!

Benefits

From health and financial benefits to time away and everyday wellness, we give Autodeskers the best, so they can do their best work. Learn more about our benefits in the U.S. by visiting https://benefits.autodesk.com/

Salary is one part of Autodesk’s competitive compensation package. For U.S.-based sales roles, we expect a starting On-Target Earnings (OTE) between $229,700 and $332,420. OTE is comprised of base salary plus commission target for sales roles. Offers are based on the candidate’s experience and geographic location and may exceed this range. In addition to base salaries and/or OTE for sales roles, we also have a significant emphasis on annual cash bonuses, stock grants, and a comprehensive benefits package.

Sales Careers

Working in sales at Autodesk allows you to build meaningful relationships with customers while growing your career. Join us and help make a better, more sustainable world. Learn more here: https://www.autodesk.com/careers/sales

Equal Employment Opportunity

At Autodesk, we're building a diverse workplace and an inclusive culture to give more people the chance to imagine, design, and make a better world. Autodesk is proud to be an equal opportunity employer and considers all qualified applicants for employment without regard to race, color, religion, age, sex, sexual orientation, gender, gender identity, national origin, disability, veteran status or any other legally protected characteristic. We also consider for employment all qualified applicants regardless of criminal histories, consistent with applicable law.

Diversity & Belonging

We take pride in cultivating a culture of belonging and an equitable workplace where everyone can thrive. Learn more here: https://www.autodesk.com/company/diversity-and-belonging

Are you an existing contractor or consultant with Autodesk?

Please search for open jobs and apply internally (not on this external site).

Job Description

General position summary:

The Associate Director, Quality role will work with the GDP Operational QA Management team to ensure that medicines are distributed in the US in compliance with GDP and GMP requirements.  The position will manage the day to day Quality oversight of the Third Party Logistics provider and provide support for key stakeholders within Vertex. 

This Position Reports to: Director, GDP Operational Quality, International QA

Key Accountabilities:

• Serve as the primary contact and have oversight of Distribution and Logistics partners within the US, including:
  • Preparation and maintenance of Quality Agreements
  • Review of deviations, CAPA and changes
  • Maintaining KPIs
  • Analyze, resolve, or assist in solving compliance and customer issues.
  • Escalation of issues
• Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS
• Accountable for New Product Launch activities within the US providing distribution requirements and expectations.
• Working collaboratively with key internal stakeholders

Key Responsibilities:

• Maintain QMS within the Vertex Inc.
• Ensure distribution licences (where required) accurately reflect the current organisation, vary licence where necessary
• Support recalls, mock recalls and any other on-market activity.
• Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.
• Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.
• Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licences (or equivalent) application, audits, and Quality Agreements.
• Planning/ Preparation/supporting/hosting for Regulatory inspections
• Providing front and backroom inspection support
• Post inspection follow-up with responses and CAPAs (Continuous improvements)
• Manage/Approve/Assess event investigations “deviations” (including Fast Track deviations)
• Manage CAPAs and Effectiveness Checks
• Perform other duties as per GDP guidelines and Vertex policies and procedures
  • Work with Vertex Product Complaints team to ensure that customer complaints are dealt with effectively.
  • Ensure that customers and suppliers are approved
  • Approving any subcontracting activities that may impact GDP.
  • Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
  • Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock.
  • Ensure that any additional requirements imposed on certain products by national law are adhered to.
• Create/review and approve Standard operating Procedures and other Quality Documents

Minimum qualifications:

Master’s degree and 4-5 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 9+ years of relevant work experience, or relevant comparable background.

Preferred Qualifications:

• Bachelor's in a scientific or allied health field and relevant GDP & GMP work experience, or relevant comparable background.
• 5+ years’ experience serving in a Quality role.
• Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
• Influencing skills in areas with no direct reporting authority.
• Strong interpersonal and communication skills.
• Auditing skills, appropriate qualifications in auditing an advantage.
• Fluency in English is required
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as: 

Hybrid: work remotely up to two days per week; or select

On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid

Company Information

Job Description

General Summary:

The Quality Systems Director provides technical and strategic leadership for quality systems, quality governance, and quality culture for the cell and gene therapy business unit.  This position focuses not just on the “what” but the “how”, ensuring phase appropriate quality compliance

***This is a hybrid role working 3 days on-site and up to 2 days remotely.**

Key Duties and Responsibilities:

• Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies
• Leads and drives improvements to quality governance forums identifying risks and driving overall compliance and quality maturity
• Provides oversight, support, and drives continuous improvement to quality systems such as change control.  Focuses not just on the process, but the content and compliance of the executed records and helps drive maturity throughout the overall organization.   
• Participates in cross-functional projects in Quality expert and leader role
• Collaborate with internally and external business partners across the organization
• Provides strategies and tactics to address compliance gaps or determines enhancements to improve the overall quality culture of the programs
• As a people manager within the organization, provides leadership, development and coaching to staff, in addition may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Expert knowledge of global GMP requirements governing CGT products
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Strong technical knowledge including but not limited to: QMS, risk management, change control and governance.
• Solid quality culture knowledge and understanding of how to influence and improve overall compliance
• Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
• Experience across multiple GxP areas
• Proven ability to identify and analyze performance indicators.

Education and Experience:

• Bachelor's degree in a scientific discipline, operations research, operations management, or a related field
• Typically requires 10 years of relevant experience and 2 years of supervisor/management experience, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Company Information

 

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

 We are looking for professionals to grow with us and we have an exciting opportunity in our Finance group.  The Director US Tax Compliance - in close alignment with the Regional Head of Tax Americas - will manage the tax compliance processes for Lonza US entities (timely preparation and filing of all federal, state and local tax returns,  management of direct and indirect tax audits, tax support to Lonza businesses) and will work in the specific tax projects (research, studies, analysis, preparation of memos and presentations etc.) assigned by the Regional Head of Tax Americas

In this role, the Director US Tax Compliance will work with the Lonza US tax team/staff, by managing and coordinating the necessary activities, and will be directly involved (“hands-on”) in the preparation/review/analysis needed to successfully execute the tax compliance processes and the projects assigned.   

Key responsibilities:

• Coordinate the timely preparation and review of all federal, state, local tax returns for Lonza US Group US (including the US tax compliance of the non-US legal entities owned via Lonza US group) to ensure timely filing and compliance with applicable laws and regulations.  Manage the process of the return preparation by Lonza US tax team/staff.  Collect, analyze, and format financial information, work with Lonza US finance and accounting departments to gather information needed to complete all required tax forms/reports.  Manage tax compliance team/staff to assist in the collection of data and ensure that the information is properly reviewed to minimize errors.  Set deadlines with tax compliance team/staff for the completion of projects so that sufficient time is available to review information in detail prior to filing with tax authorities.
• Maintain tax software to be used to prepare all federal and state tax returns for Lonza US entities. 
• Maintain a tax depreciation software database to be used in order to correctly calculate the Federal and State Depreciation adjustments. 
• Preparation and review of estimated tax payments calculations to minimize excess tax payments and liaising with Lonza US Treasury department to pre-inform on the payments amount expected and to be executed.
• Investigate and implement tax optimization opportunities, including income exclusions and tax credits, to be pre-discussed and aligned with the Regional Head of Tax Americas. Ensure that best practices are employed to efficiently gather, use, document, and maintain the related supporting documentation in line with the applicable law and regulations. 
• Maintain professional and technical knowledge by attending educational workshops or classes; reviewing professional publications; establishing personal networks, and participating in professional societies.
• Manage the various tax notices and exams in such a manner that the position is knowledgeable enough of the laws/requirements so that the position can answer IRS and or state authority’s questions and concerns.
• Assist in the effective and efficient tax transition and consolidation of newly acquired Lonza’s entities under the Lonza US tax umbrella.
• Perform tax analysis/researches and prepare memorandums and presentations in relation to specific tax projects assigned by the Regional Head of Tax Americas
• Manage, under the lead of (and in close alignment with) the Regional Head of Tax Americas, federal, state & local tax audits from various US jurisdictions, negotiate with tax authorities and defend the positions taken by Lonza by maintaining complete and accurate files.  Make sure that sufficient information is gathered and maintained during the tax returns process to support amounts that might be questioned in the future under audit.
• Responsible for FATCA Compliance and maintaining W-8BENE forms and W-9 forms for all units within and out of the US.
• In close alignment with the Regional Head of Tax Americas, manage tax compliance team/staff and recommend and encourage training seminars to help them improve their tax knowledge and develop their careers.  Provide feedback to staff on projects completed.
• Align with Regional Head of Tax to ensure that Lonza’s global and US tax strategies and optimization of Lonza’s tax position are implemented and correctly reflected in the US tax returns and provisions.
• Frequently liaise with Regional Head of Tax Americas to discuss Lonza’s US tax position in general, and with respect to specific items identified as (materially) influencing Lonza’s US tax position. Timely inform Regional Head of Tax Americas about tax audits announced, and keep Regional Head of Tax Americas informed about progress and status of tax audits, discussing general approach, what information will be provided, negotiation positions, and the response to proposed adjustments.

Key requirements:

• Bachelors’ degree required, Masters’ degree in Taxation/Accounting preferred
• Significant years of experience in US Corporate Tax Compliance and Tax Accounting
• Experience leading multiple complex initiatives simultaneously
• Flexibility and willingness to perform other tasks assigned
• Ability to gather and organize large amounts of highly technical and specialized information from numerous sources
• Significant work experience interfacing with Tax function colleagues in US and Globally
• Highly proficient with time and process management

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Job Description

General Summary:

The Quality Compliance Director provides strategic leadership for quality culture, inspection readiness, clinical to commercial transition, and escalation process for the cell and gene therapy business unit.  The role has specific focus on external and internal manufacturing/testing inspection readiness and ongoing compliance to changing regulatory expectations.  This position focuses not just on the “what” but the “how”, ensuring phase appropriate quality compliance. 

***This is a hybrid role working 3 days on-site and up to 2 days remotely.**

Key Duties and Responsibilities:

• Provides tactics to address compliance gaps or determines enhancements to improve the overall quality culture of the programs
• Leads inspection and compliance programs both internally and externally.  Works cross-functionally across many different functional areas and programs. 
• Provide leadership, strategic thinking, and mentorship to staff, focusing on employee development and leadership skills
• Leads and manages complex projects/teams within corporate objectives and project timelines
• Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into inspection readiness and control strategies
• Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
• Be directly involved in and where appropriate, lead multiple process/product improvement projects which may include quality system process improvements, development of new methodologies and improving existing methodologies, data generation, report development and presentation
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Expert knowledge of global GMP requirements governing CGT products

  • Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams

  • Ability to evaluate quality matters and make decisions utilizing risk-based approach

  • Solid quality culture knowledge and understanding of how to influence and improve overall compliance

  • Strong presentation skills and ability to influence others

  • Proven ability to identify and analyze performance indicators.

Education and Experience:

• Bachelor's degree in a scientific discipline, operations research, operations management, or a related field
• Typically requires 10 years of relevant experience and 2 years of supervisor/management experience, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Company Information

Job Description

General/Position Summary

The Senior Director, Quality be responsible for the oversight of Product Quality/ External Manufacturing of Cell & Gene Programs.  The role will be responsible for supporting the commercial transition of the Cell & Gene quality  strategy to meet business, regulatory and operational requirements.

The is a critical role within Quality department responsible for managing CDMO partnerships to ensure that the company effectively and efficiently delivers medicines to patients. This role is also directly responsible for co-leading joint project teams with CDMO’s.

This position will be based in Vertex’s corporate headquarters in Boston, MA. This role will partner closely with operational stakeholders to ensure seamless supply of all clinical and commercial products and to lead/support the development and execution of quality projects.   The senior director of quality will also participate in Cell & Genetic therapies projects and governance committees covering external manufacturing. 

**This is a hybrid role working 3 days on-site and up to two days remotely.**

Key Duties & Responsibilities

• Establishment of quality oversight for external CMO operations.
• Prioritize, develop and implement systems, processes and tools to ensure that the systems, processes and resourcing are optimal for transition from development through product life cycle and set up to scale efficiently and effectively.
• Ensure appropriate metrics and tracking are in place for operational monitoring and as early key indicators for operational issues.
• Represent Quality in Cell & Gene Programs and serve as a trusted advisor and partner to establish the CMC quality strategy and roadmap for innovative therapeutic programs.
• Support GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.
• Provides quality leadership and partner with operational stakeholders to ensure efficient operations and mitigation of risks. Support/lead risk management activities, including identification of gaps, implementation of mitigation plans and associated execution.
• Provide significant CDMO-focused regulatory filing input (IND, BLA, etc) and drive operations-focused pre-approval inspection and commercial readiness activities at the CDMOs.  Adjudicate compliance discussions, and negotiate any required corrective actions.
• Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.
• Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence.
• Lead and mentor other team members, support development of organizational capabilities and talent building.

Required Education Level

• Bachelor’s and Master's degree in a Scientific/Technical/Business discipline.

Required Experience

• 15+ years of experience and 7+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Required Knowledge/Skills

• Experienced in quality assurance operations role  for a allogeneic/autologous cell manufacturing process.
• In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
• Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.
• Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
• Current knowledge of industry trends and best practices in Cell/Gene therapies.
• Operational Excellence experience with proven ability to lead improvement projects-Experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
• Ability to apply risk management principles to decision making and operational priorities.
• Critical Thinking and Problem Solving skills

Other Requirements
 

15% travel

Hybrid role in Boston, MA

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Company Information

Career Category

Operations

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

DIRECTOR, CLINICAL QUALITY THERAPEUTIC AREA LEAD

Live

What you will do

Job Description

Let’s do this! Let’s change the world! In this vital role you will report to the Associate Vice President, Clinical & Research Quality (CRQ) and be responsible for a team of 5-10 colleagues. The Director, Clinical Quality Therapeutic Area Lead provides proactive end to end quality oversight strategies for the development and implementation of a customized risk-based quality assurance strategy for the clinical development program.

Director, Clinical Quality Therapeutic Area Lead will manage end to end Quality Oversight within one of three Therapeutic Areas (TAs): Oncology/Biosimilars, Immunology & Rare Diseases, and General Medicine. The TA Lead is responsible for implementing a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).

You will be a vital role who develops deep knowledge of the TA’s clinical trials and provides oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.

Responsibilities

• Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes
• Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights
• Provide oversight for the development and implementation of Quality Plans
• Establish Regional expertise to ensure quality and compliance to local regulations
• Support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)
• Develop TA-specific Quality Assurance plans that are risk based and efficient. This includes TA specific audit plans, and the execution of audits (investigator site audits, affiliate audits, and study level audits)
• Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness activities, and Inspection Management, and Serious Breaches/ Privacy Issues
• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:

Basic Qualifications:

Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience

Or

Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience

Or

Bachelor’s degree and 10 years of Quality Management, Quality Assurance, or other relevant experience

In addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• 5 years of managerial experience directly leading people in a multi-tiered organization and an ability to build a high performing team.
• 5 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise. (including oversight of CAPAs, deviations, etc.)
• Thorough understanding and deep knowledge of Clinical Development activities / Clinical Trials and Global Regulations.
• Knowledge of the Regulatory Submission and Inspection Management procedures.
• Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.
• Excellent verbal and written communication skills, including strong business writing abilities and active listening.
• Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format.
• Strong analytical, critical-thinking, and decision-making abilities.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Salary Range

187,972.00 USD - 214,012.00 USD