Quality Manager Design & Qualification (all genders) - limited until 30.06.2028

Kurz zusammengefasst

Sanofi is constructing a state‑of‑the‑art, fully automated insulin drug substance plant in Frankfurt. The project, part of a once‑in‑a‑generation initiative to modernise insulin production, will serve the entire insulin portfolio from early development through to commercial delivery. As Quality Manager Design & Qualification (IFF), you will join a cross‑functional programme team responsible for bringing the facility from concept and construction to commercial readiness, ensuring that every design, commissioning and qualification activity meets the project's Validation Master Plan and global regulatory standards. In this role you will supervise all commissioning, qualification and validation work for the IFF project, guaranteeing alignment with cGMP design concepts and quality requirements. You will support the Process Engineering team during design reviews, develop and roll out the commissioning and qualification strategy, and prepare the necessary protocols, reports and master plans. The position also includes oversight of supplier qualification activities such as factory acceptance tests, site acceptance tests and vendor documentation, while fostering a culture of compliance and continuous improvement across the site and future locations. The role requires an advanced academic background in engineering, science, pharmacy or a comparable discipline, with a master's or doctoral degree being preferred. Candidates must have three to five years of experience in the biopharma or a similarly regulated sector, and a proven track record in quality‑system management, process‑validation lifecycle and Quality‑by‑Design approaches. Strong knowledge of pharmaceutical manufacturing processes, GxP regulations and international regulatory expectations, including FDA requirements, is essential. Excellent leadership, communication and decision‑making abilities are also required, as is fluency in English; German or French language skills are considered advantageous. Sanofi promotes an inclusive environment where diverse backgrounds and perspectives drive innovation. The position is based in Frankfurt, offering the chance to work on a landmark facility that will impact millions of people living with diabetes. The salary range is €80,724, €107,620, with final compensation reflecting experience, skills and location, and eligibility for the company's employee benefit programmes. What the role asks for: - Advanced degree in Engineering, Science or Pharmacy - MSc or PhD (preferred) - 3‑5 years experience in biopharma or regulated industry - Proven experience in Quality System Management - Experience in Process Validation Lifecycle - Experience with Quality by Design principles - Proficiency in English - German language knowledge (nice‑to‑have) - French language knowledge (nice‑to‑have)