Global Quality Assurance Manager

Location: Basel

Duration: 1 year/possible extension

An exceptional candidate holds a Bachelor's degree in a relevant scientific or technical field and brings a minimum of three years of comprehensive Quality Assurance experience deeply rooted in a regulated GMP/GDP environment. They are completely fluent in English (with German being a strong asset), allowing them to confidently author Master Quality Agreements, manage clinical trial complaint systems, and articulate compliance strategies during high-stakes Health Authority Inspections. Finally, this individual is a proactive problem-solver who will seamlessly support clinical studies by approving complex IMP Supply & Release Flowcharts while actively driving continuous improvement projects across the distribution network.

Responsibilities:

• Regulatory Compliance: Act as the appointed Delegate of the Swiss Responsible Person (FvP), providing necessary final Quality decision-making

• Global Oversight: Maintain Global QA oversight for the entire IMP Distribution Network and its business counterparter PTDS-L.

• Lead the Deviation Management process by performing product quality impact assessments. Provide crucial Quality oversight by reviewing and assessing final evaluations and statements from third parties, ensuring consistency with regulatory standards, and checking if proposed Corrective and Preventive Actions (CAPA) are appropriate.

• System Owner: Manage the full lifecycle of quality documentation and Change Records, including establishing, reviewing, and approving critical documents and changes for both internal procedures and external business documents (PTDS-L).

• Inspection Management: Actively drive and support all GxP inspections and audits.

• Quality Decision-Making: Manage Temperature Excursion Management for clinical trials, including performing assessments and managing Expert Statements/Opinions.

• Support clinical studies by reviewing and approving IMP Supply & Release Flowcharts, Transfer requests, and Expert Opinions.

• Establish and approve Master Quality Agreements and Quality Agreements.

• Manage Complaint Management for clinical trials.

• Support quality-related and business-driven projects within the IMP Distribution network.

• Drive continuous improvement activities

• Professional Discipline: Assure GMP/GDP compliance, adhere to Good Documentation Practices (GDP), and ensure training compliance with PQS documents

Must Haves:

• A Bachelor's degree in a relevant scientific or technical field (e.g., Pharmacy, Chemistry, Biology, Engineering).

• Proven and comprehensive experience (min. 3 years) in Quality Assurance with a strong focus on compliance.

• Deep knowledge of a regulated GxP environment (GMP/GDP).

• Fluent speaker and writer in English (German is a plus).