About the role
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.
Relocation Assistance: This role is eligible for relocation support for French-speaking candidates relocating from within France or other European countries.
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%