Quality Director

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

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• Lead the full site Quality organization (QA, QC, Compliance, Validation, Quality Systems)
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• Act as the registered Qualified Person (QP) for the site
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• Ensure compliance with French, EU, FDA, and global regulatory standards
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• Lead regulatory inspections and manage interactions with ANSM, EMA, FDA, and other authorities
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• Drive a proactive quality culture with strong risk-based decision-making
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• Oversee CAPA, deviations, change control, complaints, validation, and inspection readiness
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• Support NDA submissions and regulatory filing activities
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• Partner cross-functionally with Operations, Supply Chain, Technical, and Global Quality
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• Develop and lead a large, multi-layered Quality organization (8–10 direct reports; 100+ indirect)
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• Champion continuous improvement initiatives (PPI, Lean, DMAIC, 8D)

Qualifications & Experience

Key Requirements

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• French Pharmacist degree enabling registration as a Qualified Person (QP)
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Fluent in French and English

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• 10+ years’ senior Quality leadership experience within regulated pharmaceutical manufacturing
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• Proven experience managing both QA and laboratory operations
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• Experience operating as a Site Quality Lead and member of a site leadership team
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• Strong experience leading regulatory inspections (French and international authorities)
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• Experience within an industrial GMP manufacturing environment (OSD preferred)
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• Experience supporting or managing NDA submissions

Preferred

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• CDMO experience with client-facing quality governance
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• Lean / Six Sigma or operational excellence background

Technical Expertise

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• Deep knowledge of EU GMP, FDA CFR, and global regulatory frameworks
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• Strong command of CAPA systems, deviation management, and change control
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• Advanced application of quality methodologies (FMEA, SPC, risk management, 8D, DMAIC)
• Travel required 25-30%