Quality Manager/Deputy Responsible Person
Listed on 2026-06-20
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
Location: Rotkreuz
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About the jobAs Quality Manager and Deputy Responsible Person within our Swiss Quality Team, you are a key guardian of patient safety—driving quality excellence, ensuring regulatory compliance, and shaping the quality culture across Swiss operations. The role supports Swiss medic as the main interface for all quality‑related matters, upholds Swiss regulatory standards, and contributes to Sanofi’s global launch platform.
Main responsibilities- Act as Deputy Responsible Person for wholesale, import/export, and trading abroad activities in accordance with Swiss MPLO regulations (812.212.1), in the absence of or as delegated by the Responsible Person.
- Partner with the RP to establish and continuously improve a robust, compliant Quality Management System aligned with Sanofi Global and Swiss regulatory requirements.
- Independently manage market batch releases, deviations, returns, and destructions with a high degree of accountability and precision.
- Support the Responsible Person in communications with Swiss medic and other health authorities, actively preparing for and managing health‑authority inspections and internal quality audits.
- Lead CAPA responses to inspection and audit findings, ensuring timely and effective resolution with thorough documentation.
- Ensure quality oversight of third‑party partners involved in GDP/GMP activities, including quality agreements and risk‑based audits.
- Review and approve documents within the RP’s area of responsibility, ensuring full compliance with Swiss regulations and driving proactive Quality Risk Management initiatives.
- Drive a strong quality culture across all functions, providing leadership and guidance on quality standards, processes, and GDP requirements while representing quality in cross‑functional projects.
Several years of progressive, hands‑on experience in a pharmaceutical quality environment (GMP/GDP). Solid, demonstrable knowledge of Swiss medic requirements, EU GMP, and EU GDP regulations. Proven experience with batch release, deviation management, and CAPA processes.
Soft and Technical Skills- Strong decision‑making capabilities in fast‑paced, innovative environments.
- Demonstrated leadership skills with the ability to drive quality mindset and organisational change.
- Excellent interpersonal and communication skills, with experience working across diverse cultures and functions.
- Open‑minded, continuous improvement orientation with a proactive approach to problem‑solving.
University degree in Life Sciences or Pharmacy.
LanguagesExcellent command of German and English, both written and spoken.
Benefits- Flexible working hours and a hybrid work model (3 days in office/2 days remote).
- 14‑week paid family time after the birth of a child for both parents.
- Health insurance, mental and physical health offerings, and leave for caregiving relatives.
- Structured onboarding, training opportunities, and international career possibilities.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
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