Quality Director

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Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Quality Site Director (QP) – OSD ManufacturingLocation: 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 & ExperienceKey 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%