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% Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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