Join Sanofi as the Compliance Head for the U.S. FDA and play a pivotal role in ensuring GMP inspection readiness across our network. Leverage your extensive experience to drive compliance, enhance quality systems, and lead digital transformation initiatives while contributing to life-saving healthcare solutions.
Key Responsibilities
Ensure US FDA GMP Inspection Readiness for sites
Enhance inspection readiness through quality system assessments and audits
Oversee FDA inspection preparation and response management
Coordinate and prepare briefing materials for US FDA inspections
Support preparation, execution, and closure of regulatory inspections
Maintain oversight of Sanofi’s aggregate GMP US FDA findings
Lead cGMP compliance projects
Drive digital transformation initiatives
Represent Sanofi externally at key industrial meetings
Foster a culture of quality and cGMP compliance
Required Qualifications
Master’s degree in science, pharmacy, engineering, data science, or equivalent
Current or recent employment at US FDA (within last 3 years)
More than 10 years of US FDA experience
15 years of relevant experience in pharmaceutical, biotech, medical device, or related industries
Extensive knowledge of Quality Systems and Data Integrity
Strong command of manufacturing processes, validation principles, risk assessment methodologies, and statistical techniques
Minimum of eight years of professional experience as an auditor and/or inspector
Previous experience interfacing with Regulatory Authority Inspectors
Inclusive, transformational, pragmatic leadership
Fluency in French is a plus
Preferred Qualifications
Member of International Society for Pharmaceutical Engineering (ISPE), BioPhorum, BSI, and/or Parenteral Drug Association (PDA)
Experience in authoring guidance documents and/or white papers
French speaking is a plus
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks of gender-neutral parental leave