Total 2 Director/C-Level Quality Assurance / Control job vacancies in 1IQ FORT DRUM NY

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As Associate Director Clinical QA, you will be trusted to provide input and assist in establishing the vision and strategic direction for Clinical R&D activities in the R&D, QA, GCP, GLP and Medical Safety Operations Groups at our Main Campus in Fort Worth, TX.

POSITION PURPOSE

• Provides input and assist in establishing the vision and strategic direction for Clinical R&D activities as part of the R&D QA GCP, GLP and Medical Safety Operations Group.
• Provides Clinical QA oversight to ensure that global Clinical Operations activities conducted by Alcon for its medical devices and pharmaceutical products are in compliance with applicable regulations, guidelines and/ or quality standards.
• Manages the Good Clinical Practice (GCP) audit program across all Alcon franchises to assure clinical related activities are conducted according to Alcon and quality standards and applicable regulations with high degree independence.  

In this role, a typical day will include:

• Provides leadership and sound business ethics in the interpretation and implementation of global GxP compliance programs, computer system and/or software validation and related services and compliance training while ensuring Clinical QA independent assessments.
• Supports clinical research and development activities for all Alcon franchises and Technology Platforms to maximize standardization and compliance.
• Advises senior management of the need for corrective and preventive actions with a key advisory role in the development of action plans and monitoring of effectiveness of action plans as a result of internal and/or external Regulatory audits.
• Ensures senior management awareness of compliance issues impacting regulatory acceptability, by appropriately escalating as per quality risk management.
• Provides support to relevant functions on proper identification and escalation of quality related issues.
• Trends, interprets and presents compliance data and metrics according to worldwide legal and regulatory requirements and Alcon standards.
• Drives/facilitates projects in collaboration with stakeholders to evaluate and or implement quality/compliance improvement initiatives.
• Leads or support cross-functional teams to evaluate impact of process changes to systems and related processes, to research best practices, determine solutions and manage change.
• Develops unique approaches to promote and instill a culture of quality and compliance.
• Provides coaching, and aid in the development of RDQA Clinical staff and business partners.
• Provides consultation and education including, but not limited to interpretation of global regulations and guidelines such as GCP, US FDA EU MDR, ISO Standards, etc.
• Authors or reviews & approves documentation including but not limited to audit schedule, plans and reports, documents associated with regulatory submissions, notes to file, study protocols, document templates, plans and reports, and clinical evaluation documents.
• Leads and supports the investigation of deviations and other quality issues detected from any source e.g., monitoring and data management, trends, signals, etc. 
• Provides guidance, review, and approval of associated deviations (NCI, CAPAs and Actions) and evaluates effectiveness.
• Provides R&D QA support to Supplier Evaluation Teams, and function as Clinical SME for service providers.
• Leads audit & inspection preparation, conduct and remediation as needed, for both national and local inspections (e.g., FDA, EMA, MHRA, TUV etc.).
• Contributes to cross-divisional activities including but not limited to FAA, FSCA and/or Market Actions/ Investigational Product Field Actions as assigned.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs).
• The ability to fluently read, write, understand, and communicate in English.
• 7 Years of Relevant Experience
• 5 Years of Demonstrated Leadership
• Work hours: Exempt
• Travel Requirements: up to 20% as needed.
• Relocation assistance: No
• Sponsorship available: No

PREFERRED QUALIFICATIONS:

• Bachelor’s degree in science or technology.
• QA work experience in a regulated Medical Device / Pharmaceutical Industry.
• Strong R&D experience and knowledge, with manufacturing experience desired.
• Proven personnel management experience.
• Advanced knowledge of ISO 14155/ 14971, 13485, ICH 6, Medical Device and Pharmaceutical EU and FDA 21 CFR 820 / 211 regulatory requirements.
• Highly proficient in MS Office.
• Highly proficient in data analytics, critical thinking, and decision making.
• Proven influencing and negotiating skillset.
• Ability to lead virtual teams and function in a matrix organization, with project management experience desired.
• Advocate for exceptional Quality and Compliance Standards - does not compromise on customer expectations and regulatory requirements.

HOW YOU CAN THRIVE AT ALCON:

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

Job Family:

Travel Required:

Clearance Required:

What You Will Do:

Guidehouse has a very aggressive growth strategy for its Financial Crimes, Fraud and Investigations (FFI) practice, and now seeks to expand its leadership team by recruiting a strong business building executive who will be a fundamental to this growth strategy.

This new hire will be a senior business builder with a high-profile personal franchise with financial crime and sanctions compliance expertise.

• Leading projects involving money laundering and sanction, fraud and other financial crime, providing deep subject matter expertise.
• Developing and leading relationships with current and prospective clients – both externally and internally, establishing credibility with senior Guidehouse colleagues in order to be recognized as a market leader. 
• Spearheading the development of a key go-to-market strategies for GIC’s Financial Crimes, Anti-Money Laundering, Sanctions practice including new client development and existing client expansion with personal pursuit.
• Manage executive level relationships across the GIC client base and ensure that there are the optimal range of AML solutions to meet client needs as well as to maximize revenue generation and profitability of the firm.
• Assessing Financial Crimes compliance programs and implementing recommended changes/controls and solutions as well a working with other FFI leaders to contribute to the development of intellectual property and thought leadership.
• Developing collaborative relationships with the other related specialty practices and non-specialty practices across the firm to cross-sell relevant products and services.             
• Playing a vital role in managing and developing team members in the Financial Services practice, as well as recruiting new team members as part of this strategic initiative to aggressively growing the GIC practice.
• Evaluating internal control structures to help identify weaknesses and associated risks.
• Evaluating the general risk faced by the client and the impact of those risks on the organization. 
• Developing, performing and supervising detailed financial, economic and statistical analysis.

What You Will Need

• 12+ years of experience with senior executive experience at any/all of the following: financial institutions, regulatory/government, client service/consulting or other relevant arenas
• Deep understanding of AML regulations, investigations, and enforcement actions
• Familiarity with common fraud and money laundering schemes
• Strong understanding of corporate governance and regulatory issues that could affect an organization.
• Outstanding project management skills in monitoring billing of hours, training, development and supervision
• Outstanding communication and public speaking skills
• Proven track record of successful new business generation, and demonstrable ability (or commercial potential) to sell, deliver and manage highly visible engagements demonstrated by year over year credited sales generation of $2M+
• Proficient in MS Access, Visio, Word, Excel, PowerPoint
• Bachelor’s degree from an accredited college/university in accounting, finance, economics or related discipline
• Able to travel up to 50%

What Would Be Nice to Have:

• Presence and credibility to successfully collaborate and work with Guidehouse’s own highly regarded business development team.
• Desire to collaborate with other related Guidehouse practices as well as across the entire global firm in order to cross-sell relevant products and services, in addition to being a growth oriented, vertical thinker.
• Intellectually adept with superior negotiation and influencing skills and ability to relate to range of senior level internal and external stakeholders.
• Elevated level of business acumen and commercial awareness.
• Extremely driven, energetic and able to thrive in a results-oriented, entrepreneurial, analytical environment.
• Additional deep subject matter expertise in forensic accounting would be desirable.

What We Offer:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

• Medical, Rx, Dental & Vision Insurance

• Personal and Family Sick Time & Company Paid Holidays

• Position may be eligible for a discretionary variable incentive bonus

• Parental Leave and Adoption Assistance

• 401(k) Retirement Plan

• Basic Life & Supplemental Life

• Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts

• Short-Term & Long-Term Disability

• Student Loan PayDown

• Tuition Reimbursement, Personal Development & Learning Opportunities

• Skills Development & Certifications

• Employee Referral Program

• Corporate Sponsored Events & Community Outreach

• Emergency Back-Up Childcare Program

• Mobility Stipend

About Guidehouse
Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.