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Quality Director
Thermofisher · Bourgoin-Jallieu, France
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Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Quality Site Director (QP) – OSD Manufacturing Location: Bourgoin, France (Site-Based) Business: Pharma Services Group (PSG) – Drug Product Division (DPD) | CDMO At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Within our Pharma Services Group (PSG), we partner with pharmaceutical and biotech companies to accelerate drug development and deliver life-changing therapies worldwide. We are seeking an experienced and strategic Quality Director (Qualified Person) to lead the Quality organization at our Bourgoin OSD (Oral Solid Dose) manufacturing site. This is a critical leadership role within a global CDMO environment, combining regulatory authority, operational excellence, and people leadership. As a member of the Site Leadership Team, you will hold full accountability for the Quality Management System, regulatory compliance, and oversight of QA, QC, and laboratory operations — ensuring the highest standards of quality, patient safety, and inspection readiness. Key Responsibilities
- Lead the full site Quality organization (QA, QC, Compliance, Validation, Quality Systems)
- Act as the registered Qualified Person (QP) for the site
- Ensure compliance with French, EU, FDA, and global regulatory standards
- Lead regulatory inspections and manage interactions with ANSM, EMA, FDA, and other authorities
- Drive a proactive quality culture with strong risk-based decision-making
- Oversee CAPA, deviations, change control, complaints, validation, and inspection readiness
- Support NDA submissions and regulatory filing activities
- Partner cross-functionally with Operations, Supply Chain, Technical, and Global Quality
- Develop and lead a large, multi-layered Quality organization (8–10 direct reports; 100+ indirect)
- Champion continuous improvement initiatives (PPI, Lean, DMAIC, 8D) Qualifications & Experience Key Requirements
- French Pharmacist degree enabling registration as a Qualified Person (QP)
- Fluent in French and English
- 10+ years’ senior Quality leadership experience within regulated pharmaceutical manufacturing
- Proven experience managing both QA and laboratory operations
- Experience operating as a Site Quality Lead and member of a site leadership team
- Strong experience leading regulatory inspections (French and international authorities)
- Experience within an industrial GMP manufacturing environment (OSD preferred)
- Experience supporting or managing NDA submissions Preferred
- CDMO experience with client-facing quality governance
- Lean / Six Sigma or operational excellence background Technical Expertise
- Deep knowledge of EU GMP, FDA CFR, and global regulatory frameworks
- Strong command of CAPA systems, deviation management, and change control
- Advanced application of quality methodologies (FMEA, SPC, risk management, 8D, DMAIC) Travel required 25-30%