IMP Quality Manager

m/f/d, Basel-Stadt

IMP Quality Operations Switzerland is responsible for delivering Investigational Medicinal Products to patients in compliance with cGMP. You will be Quality Partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and Compliance oversight of all.

• Start date: asap
• Latest Start Date: 1.09.2025
• Planned duration: 12 months

Responsibilities

Acts as a delegate of the Swiss RP for IMPs
Has the QA responsibility for GMP compliance of manufacture and analysis of IMP batches (in particular parenteral drug product batches).
Reviews and approves GMP procedures, records and reports (e.g. SOPs, master batch records, discrepancy and change records and validation reports).
Performs self-inspections in GMP plants and laboratories.
Reports directly to the RP and RP deputy.

Requirements

Bachelor or Master Degree in Life Sciences or equivalent.
Fluent German and English
Min. 3 years of relevant experience in the pharmaceutical industry.
Min. 3 years experience in a GMP regulated environment.
Min. 3 years experience all activities around parenteral manufacturing and quality control.
Demonstrated experience in a Pharmaceutical Technical Development environment.
Knowledge of cGMP and Quality requirements for clinical development stages of biotechnological and/or parenteral IMPs (e.g. EU Annex 1).
Experience in Discrepancy Management, CAPA, Technical Change Management (Veeva Vault) and Manufacturing Management (SAP), MES (PMX) and LIMS is an additional plus.