Quality Director

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><h1><b>Quality Site Director (QP) – OSD Manufacturing</b></h1><p><b>Location:</b> Bourgoin, France (Site-Based)<br /><b>Business:</b> Pharma Services Group (PSG) – Drug Product Division (DPD) | CDMO</p><p>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.</p><p></p><p>We are seeking an experienced and strategic <b>Quality Director (Qualified Person)</b> 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.</p><p>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.</p><p></p><h2><b>Key Responsibilities</b></h2><ul><li><p>Lead the full site Quality organization (QA, QC, Compliance, Validation, Quality Systems)</p></li><li><p>Act as the registered <b>Qualified Person (QP)</b> for the site</p></li><li><p>Ensure compliance with French, EU, FDA, and global regulatory standards</p></li><li><p>Lead regulatory inspections and manage interactions with ANSM, EMA, FDA, and other authorities</p></li><li><p>Drive a proactive quality culture with strong risk-based decision-making</p></li><li><p>Oversee CAPA, deviations, change control, complaints, validation, and inspection readiness</p></li><li><p>Support NDA submissions and regulatory filing activities</p></li><li><p>Partner cross-functionally with Operations, Supply Chain, Technical, and Global Quality</p></li><li><p>Develop and lead a large, multi-layered Quality organization (8–10 direct reports; 100&#43; indirect)</p></li><li><p>Champion continuous improvement initiatives (PPI, Lean, DMAIC, 8D)</p></li></ul><h2><b>Qualifications &amp; Experience</b></h2><h3><b>Key Requirements</b></h3><ul><li><p><b>French Pharmacist degree</b> enabling registration as a Qualified Person (QP)</p></li><li><p>Fluent in French and English</p></li><li><p><b>10&#43; years’ senior Quality leadership experience</b> within regulated pharmaceutical manufacturing</p></li><li><p>Proven experience managing both QA and laboratory operations</p></li><li><p>Experience operating as a Site Quality Lead and member of a site leadership team</p></li><li><p>Strong experience leading regulatory inspections (French and international authorities)</p></li><li><p>Experience within an industrial GMP manufacturing environment (OSD preferred)</p></li><li><p>Experience supporting or managing NDA submissions</p></li></ul><h3><b>Preferred</b></h3><ul><li><p>CDMO experience with client-facing quality governance</p></li><li><p>Lean / Six Sigma or operational excellence background</p></li></ul><h3><b>Technical Expertise</b></h3><ul><li><p>Deep knowledge of EU GMP, FDA CFR, and global regulatory frameworks</p></li><li><p>Strong command of CAPA systems, deviation management, and change control</p></li><li><p>Advanced application of quality methodologies (FMEA, SPC, risk management, 8D, DMAIC)</p></li></ul><p>Travel required 25-30%</p><p></p><p></p><p></p><p></p>