IMP Quality Manager

Randstad; Basel; Vor Ort; CHF 80’000 - 110’000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Basel is seeking an IMP Quality Manager to oversee GMP compliance for investigational medicines. The ideal candidate will have robust QA knowledge, particularly in sterile drug manufacturing, and strong communication skills in both English and German. This role offers a dynamic environment with key responsibilities in quality operations and regulatory oversight. Apply now to join a dedicated team focused on delivering innovative medicines to patients.

Qualifikationen

• 3+ years of experience in the pharmaceutical industry.
• 3+ years in a GMP regulated environment.
• Experience in parenteral manufacturing and quality control.

Aufgaben

• Ensures GMP compliance for IMP batch manufacture and analysis.
• Reviews and approves GMP procedures and reports.
• Performs self-inspections in GMP plants.

Kenntnisse

Quality Assurance

GMP compliance

Interpersonal skills

Negotiation skills

Communication in English

Communication in German

Ausbildung

Bachelor or Master Degree in Life Sciences

Tools

Veeva Vault

SAP

Manufacturing Execution Systems (PMX)

Laboratory Information Management System (LIMS)

Jobbeschreibung

For our client, a leading pharmaceutical company in Switzerland, we are looking for anIMP Quality Manager.

General Information :

• Duration : 12 months, with the possibility of extension
• Workplace : Basel
• Remote / home office : max 20%
• Team : 10 people
• Department : IMP Quality Operations Basel&Kau (MMQIE)
• Working hours : Standard

About the work :

IMP Quality Operations Switzerland is responsible for delivering Investigational Medicinal Products (“IMPs”) to our client’s patients in compliance with cGMP. The team is the 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.

The team's purpose is to create a space for experimentation by coaching and celebrating learnings to build a purpose driven quality community that delivers innovative medicines to patients. This position within IMP Quality Operations Switzerland requests a high level of flexibility, ability to work under pressure and sense of responsibility. If you have detailed knowledge of GMPs as well as outstanding interpersonal and negotiating skills, you should apply for this job.

Your Profile :

The “perfect candidate” has asolid Quality Assurance knowledge and experience in GMP compliancefor sterile drug product manufacturing and quality control.

Tasks & 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 at Basel.
• Reports directly to the RP and RP deputy.

Must Haves :

• Bachelor or Master Degree in Life Sciences or equivalent.
• 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.
• Ability to communicate clearly and professionally both verbally and in writing in English (C1) as well as in German (C1).

Nice to Have :

• Proficient contribution to health authority inspections and internal GMP audits

Sounds interesting?Apply now– we’re looking forward to receiving your applications!

Application Submission Deadline : 17.06.2025