Quality Director

Job description

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)

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%