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General Information
Start Date: 24.08.2026
Planned Employment Duration: 1 year, with the possibility of extension
Workplace: Basel
Workload: 100%
Home Office: 60% at the office and 40% of home office
Department: IMP Quality Distribution (PTQEAB)
Team: 7 people
Working Hours: Standard
About the job
The team is responsible for maintaining the quality and compliance of Investigational Medicinal Products (IMP) throughout the clinical supply chain and acts as the appointed Delegate of the Swiss Responsible Person (FvP) and holds Global QA oversight over the entire IMP Distribution Network (Depots) and our key business counterparter, Global Clinical Supply Chain Management Distribution (PTDS-L). They drive continuous improvement and ensure adherence to international GMP/GDP standards.
Perfect Candidate
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.
Tasks & 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: Perform 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.
Additional Responsibilities & Competencies
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 within the network.
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). Fluency is essential for managing critical regulatory documentation, providing authoritative guidance to European sites, and ensuring successful support during Health Authority Inspections.
Nice to Haves
Familiarity with Veeva vault QMS
PTQ experience
Experience in supplier management especially depots
Application Submission Deadline: 23.06.2026
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