Senior Manager Quality, EM&S Gen Med North America

Senior Manager Quality, EM&S Gen Med North America

Location:

Framingham, MA

This role reports to the Senior Director, Quality, EM&S Gen Med NA and is part of a team that has primary responsibility for providing quality oversight for 3rd party subcontractors such as CMOs, suppliers, and contract labs, to oversee activities of QA/QC and compliance functions to ensure compliance with current Good Manufacturing Practices (cGMPs) and Quality Management System (QMS). This position interacts extensively with North American manufacturing/packaging sites, contract manufacturers, and with sites inside and outside the U.S. which manufacture products that include all dosage forms for numerous global markets.

The individual works closely with the contractors, quality team, supply chain, MSAT, regulatory, and other appropriate groups to ensure compliance and continuous improvement in quality functions to ensure compliance with cGMPs and regulatory submissions.

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life‑changing treatments reach people everywhere, faster.

We’re an R&D‑driven, AI‑powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

• Bachelor’s degree in a Science field.
• 3+ years of experience in Pharmaceutical Operations or Quality Operations with the application of cGMPs in the Pharmaceutical or related regulated industry.
• Open to domestic and international travel (25-30% of time).
• Co‑op or internship experience will be considered.

• Excellent oral and written communication skills in cGMP documentation.
• Experience in third party manufacturing Quality and Regulatory function and/or same plant experience.
• Interpersonal skills to interface with suppliers and customers to develop privileged communications and relationships.
• Excellent teamwork and negotiation skills in dealing with internal and external partners with the ability to lead and manage quality related projects.
• Effectively communicate at all levels of associates in the Sanofi organization (from operator to vice president) or supplier and customer at all levels.
• The incumbent should possess significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries, especially those related to handling product complaints and the associated regulations.
• Thorough knowledge of GMP’s and regulatory requirements.
• Understanding of various drug product manufacturing including oral dosages, semi‑solids, liquids, injectables, lyophilized and medical drug/device combinations.
• Project management skills.
• Knowledge of French to effectively interface with headquarters.

• Ensures the Quality and Regulatory compliance of products subcontracted to external entities on behalf of Sanofi in accordance with cGMPs and Sanofi Quality directives.
• Ensures the efficiency of Quality System implemented between Sanofi and the sub‑contractors ensuring relevant management for complaints, deviations, change controls, non‑conformities, or any activity aiming to ensure the production, the control, and the release/disposition of products accordingly with Quality, regulatory, and procedural requirements.
• Strengthens the Quality and Regulatory strategy particularly during crisis management and verify the implementation of the relevant action plans.
• Support the External Manufacturing North America Audit program by working with and conducting contractor audits to assure compliance with Sanofi Quality Directives, current Good Manufacturing Practices (cGMPs), and regulatory filings. Leads or participates in the subcontractors audits and managers the CAPAs that follow.
• Supports and manage projects assigned such as new product launch, onboarding/offboarding or subcontractors and products.
• Id…