MSD seeks an Associate Director to lead laboratory compliance, metrology, and validation efforts at its Lucerne site, ensuring GMP standards across the global analytical network.
This position sits within the GxP compliance and documentation team of the Pharmaceutical Analysis & Digital Technologies department. The role is central to fostering a culture of quality and operational excellence throughout the company's global analytical network.
Responsibilities
- Supervise a group of specialists responsible for the maintenance, qualification, and metrology of analytical instruments in a GMP setting.
- Oversee the creation and management of GMP documentation, training materials, and standard operating procedures for the worldwide network.
- Initiate and manage investigations and change control records associated with laboratory equipment.
- Standardize analytical methods globally and contribute to or manage relevant SOPs for metrology and validation.
- Direct audit and inspection preparations for analytical groups at the Schachen location, including handling observations and implementing corrective actions.
- Perform internal compliance checks and conduct deep-dive reviews on data integrity within laboratory functions.
Requirements
- A bachelor’s degree or higher in analytical chemistry or a closely related discipline.
- At least five years of experience in the pharmaceutical sector, supporting GMP analytical testing or quality assurance.
- Strong understanding of ICH guidelines, Eudralex, PICS, and other applicable regulatory frameworks.
- Proven track record in leading teams.
- Background in supporting laboratory audits and regulatory inspections.
- Hands-on experience working within Good Manufacturing Practice environments.
Nice to have
- A clear dedication to fostering an inclusive workplace.
- Prior experience writing SOPs for GMP analytical labs.
- Familiarity with GMP documentation and training processes in pharma.
- Experience with instrument commissioning, qualification, and validation (CQV).
- Knowledge of computer system validation for laboratory instruments.
What the company offers
- Flexible hybrid work options.
- Assistance with international relocation.
About the company
MSD is a major biopharmaceutical organization with more than 1,000 employees across three Swiss sites. Recognized as a Top Employer in Switzerland and Europe, the company actively engages with the local community through health-focused initiatives like the Trendtage Gesundheit Luzern and the Alliance Health Competence.
- Awarded Top Employer Switzerland and Top Employer Europe certifications.
- Strong commitment to local community health initiatives.
- Focus on inclusion and operational excellence.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.