Job Information
Sanofi Group Associate Director, Quality Assurance in Ridgefield, New Jersey
We are seeking an experienced and detail-oriented Associate Director for our Quality Assurance Department at Ridgefield, NJ. In this role, you will lead a team of quality professionals to ensure product testing, release, and ongoing process control. Your focus will be on maintaining compliance with Sanofi's standards and regulatory requirements, while providing guidance to internal stakeholders.
Lead and manage teams focused on Deviation/CAPA, Quality Assurance Inspection, and Supplier Quality.
Provide direction and support to ensure compliance with regulatory and local requirements.
Collaborate with Subject Matter Experts (SMEs) and Manufacturing to scope and lead complex technical investigations.
Monitor batch record trends, facilitating investigations as needed.
Generate monthly and annual metrics for deviation/CAPA and report to relevant stakeholders.
Support third-party audits and prepare responses for audit observations.
Ensure quality technical expertise is provided during manufacturing investigations, particularly for OOS/OOTs, utility interruptions, and environmental monitoring excursions.
Develop investigation strategies to ensure root cause analysis is conducted accurately and within required timelines.
Approve deviations and CAPAs, ensuring proper root cause identification and effective corrective actions.
Provide training and guidance to personnel on deviation, CAPA, batch record review, and product release activities.
Lead cross-functional interactions and maintain compliance through SOP authoring and updates.
Key Competencies:
Act for Change : Embrace innovation and new ways of working.
Cooperate Transversally : Collaborate with peers, stakeholders, and partners to achieve business objectives.
Develop People : Invest in the development of yourself and your team, anticipating future business needs.
Why Join Us?
Opportunity to lead and mentor a team in a dynamic environment.
Engage in cross-functional collaborations that impact business outcomes.
Competitive compensation and benefits package.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !