1. Coordinate and supervise compliance activities within the Lengnau site.
2. Make critical decisions regarding process compliance to impact product quality.
3. Coordinate or lead QA activities including quality agreements, metrics, self-inspection, inspection readiness programs, supplier qualification, auditing, record review, final product functions, complaints, document management, risk management, and oversight of quality systems and investigations within QA.
4. Manage the lifecycle of associated concepts/programs, policies, and procedures.
Education
5. A Master's degree in a life science field is required. Equivalent work experience and knowledge can substitute.
Experience & Proficiencies
6. More than 10 years of proven experience in the pharmaceutical industry.
7. Excellent knowledge of Operations and Quality Assurance for biological pharmaceuticals (cGMP) with over 5 years of experience.
8. In-depth knowledge of Quality practices, cGMP regulations, and international health authority guidelines (especially Swissmedic and US FDA).
Additional Requirements
9. On-call services (picket light / 2nd level remote), based on department organization.