QC Compliance Specialist

The QC Compliance Specialist has a primary role in:

• Representing QC for the processes led by QMS team at site level
• Investigating in a timely manner and resolving any quality control events, issues, or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs
• Managing the consolidated follow-up and progress tracking of events (eg deviation, lab investigations), change control and CAPAs, related to QC, coordinating with respective QC areas and other involved functions, to ensure they are managed and closed as committed
• Contributing to develop, implement, and maintain an effective compliance program for QC
• Ensuring issuance and approval of appropriate local quality control documentation, when required to support the QMS processes applicable to QC, in alignment with the site QMS
• Investigating on a timely manner and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs
• Providing support during regulatory inspections and audits
• Leading initiatives for continuous improvement in QC, in coordination with QC excellence team
• Ensure compliance to Good Manufacturing Practices (cGMP) at all times

• Third Level qualification (degree in science or related discipline preferred)
• Experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements
• Experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up
• In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH)
• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions
• Proficiency in identifying issues and implementing effective solutions to resolve quality control problems
• Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

#LI-EUR

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.