Quality Director

Work Schedule

Standard (Mon\-Fri)Environmental Conditions

OfficeJob Description

Quality Site Director (QP) – OSD Manufacturing
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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
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• 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)

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