Description
Director Quality Assurance & Production Management (100%)
Description
Our client is an established Swiss pharmaceutical company with an international presence, specializing in prescription and OTC products in gynecology, dermatology, and phlebology. In addition to strengthening their international operations, they’re looking for an experienced leader to take full ownership of Quality Assurance and Production Management, driving strategic improvements and operational performance, based in Switzerland. Their global manufacturing network requires robust quality standards, efficient production processes, and close collaboration with external partners.
Responsibilities
- Lead global Quality Assurance and Production Management, overseeing international teams, resource planning, budgets, KPIs, and operational performance.
- Define and implement global quality and compliance strategies, ensuring adherence to GMP, GDP, ISO 13485, and regulatory requirements.
- Oversee and continuously improve the Quality Management System (QMS), including deviations, CAPAs, change control, audits, risk management, and quality investigations.
- Manage external manufacturing partners and CDMOs, ensuring supplier qualification, quality agreements, manufacturing compliance, and operational excellence.
- Drive technology transfers, manufacturing transfers, process optimization, validations, and the integration of new products and production partners.
- Lead regulatory inspections, continuous improvement initiatives, and manufacturing expansion activities.
Requirements
- Degree in Pharmacy, Life Sciences, Chemistry, or a related scientific discipline.
- Extensive leadership experience combining pharmaceutical production operations and Quality Assurance within regulated manufacturing environments.
- Strong hands-on manufacturing background, including production processes, operational management, and international manufacturing networks.
- Proven experience managing CDMOs, external manufacturing partners, technology transfers, and complex quality and compliance processes.
- Strong knowledge of GMP, GDP, ISO 13485, and QMS requirements; Qualified Person (QP) certification or relevant Deputy QP experience is highly desirable.
- Fluency in German and English, strong international leadership capabilities, and willingness to travel approximately 50% across European sites.
