Head of GMP GDP Audit and Inspection – Commercial
| Company | Sanofi |
|---|---|
| Location | Bridgewater Township, NJ, USA, Morristown, NJ, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Master’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Minimum master’s degree in science, pharmacy, engineering, data science, business or equivalent
- At least +15 years relevant experience in the pharmaceutical, biotech, medical device, or related industries or at a major regulatory authority
- Strong understanding of manufacturing processes, validation principles, risk assessment methodologies, contamination control and Annex 1, and statistical techniques
- Eight or more years of experience as an auditor and/or inspector
- Five or more years previous experience interfacing with Regulatory Authority Inspectors from different regions of the world
- Extensive knowledge of Quality Systems and Data Integrity
- Inclusive, transformational, pragmatic leadership
- Change management
- Excellent communicator
- Fluent English, French speaking is a plus
Responsibilities
- Design, develop and implement risk-based Auditing Strategies for GMP GDP Network
- Lead team to prepare, perform and follow-up Mock Inspection activities across Manufacturing & Supply Network to ensure preparedness
- Support Inspections by major International Regulators across Manufacturing & Supply Network
- Core Member of GMP GDP Quality Governance Committee, deputy decision-maker for Head of Quality Audit, Inspection & Intelligence
- Acts as main point of contact in ‘Reverse Due Diligence’ activities, and participates in Due Diligence, as and when needed
Preferred Qualifications
-
No preferred qualifications provided.