Reports to: Head of QA
Location: Daix (21), France — Remote work possible
About Inventiva
Inventiva is a clinical-stage biopharmaceutical company headquartered in France, focused on the development of lanifibranor in a Phase 3 trial, NATIV3, in MASH. To learn more, please visit: https://inventivapharma.com/
We are strengthening our CMC quality function and seeking a QA CMC Manager to ensure that our drug manufacturing processes meet global GMP standards.
The Opportunity
The QA CMC Manager will play a pivotal role in ensuring that our drug manufacturing processes meet global GMP standards. This role focuses on quality oversight of CDMOs, validation of commercial processes, and ensuring CMC readiness for regulatory filings.
Key Responsibilities
CMC Quality & Manufacturing Oversight
- Establish quality governance across the external network
- Provide QA oversight from KSM to Finished product
- Technical transfers and process lifecycle management
- Global CMOs & CDMOs qualification, audit and oversight
- Oversee and approve QTAs with all CMOs and other vendors
- Lead investigations into deviations, OOS (Out of Specification) results, change control and CAPAs related to CMC activities
- Define and set a quality performance review with relevant KPIs with CMOs
Validation & Commercial Readiness
- Define the strategy and requirements for validation (incl. process, analytics, IT system, transport, etc.)
- Lead the QA review of Process Performance Qualification (PPQ)
- Oversee global Validation programs (manufacturing, QC, cleaning, transport, etc.)
- Define the strategy for stability studies for commercial packaging
Batch & Product Release
- Review and approve batch manufacturing, packaging and QC records
- Oversee release of drug substances, drug products and clinical supplies
Regulatory & PAI Readiness
- Review CMC sections of the NDA (New Drug Application) or MAA
- Ensure “Data Integrity” across all CMC records
- Support successful preapproval inspection of CMOs
Global Quality Assurance for Commercial Distribution
- Coordinate centralized selection and qualification of global transport and storage partners
- Support supply chain and distribution operational readiness (GDP framework) by scheduling and performing regular audits
Other
- Lead and mentor GMP QA team
- Organize GMP training programs
Experience and Qualifications Required
- Advanced degree (Master or PhD) in a health-related discipline or equivalent experience
- At least 8 years’ experience in a similar position (Pharma or Biotech company)
- Solid Dosage Experience: expertise in GMPs for dry forms
- Regulatory Knowledge: in-depth knowledge of ICH Q7 (API), ICH Q11, and ICH Q8/Q9/Q10 (Quality by Design & Risk Management)
- CDMO Management: experience auditing and managing external chemical manufacturing sites; Validation Master Plan (VMP); audit and inspection
- Ability to work with cross-functional teams
- Strong sense of priorities and problem-solving oriented
- Collaborative skills and committed team player
- English fluent (written and spoken)
Why Join Us
- Join the company at a transformational moment
- Work closely with experienced executive leadership during a critical growth phase
- Opportunity to shape scalable CMC quality programs for a potential commercial organization
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.