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Quality assurance manager (drug product clinical manufacturing)

Basel
Randstad Switzerland
EUR 115’000 pro Jahr
Inserat online seit: 18 März
Beschreibung

For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a QA Manager - Drug Product Clinical Manufacturing.

General Information:

* Start Date: 01.04.2026
* Latest Possible Start Date: 01.05.2026
* Planned Employment Duration: 12 months contract with the possibility of extension
* Workplace: Basel
* Home Office: possible, 20%, on site presence required
* Team: 10 People
* Department: IMP Quality Operations Basel & Kau (MMQEB)
* Working Hours: Standard

About the job:

The Synthetic Molecules IMP Quality Group is responsible for quality oversight of the Synthetic Molecules Drug Substance and Drug Product facilities, as well as the associated quality control. As an employee of the IMP Quality Organisation Switzerland, you will ensure compliance with and continuous improvement of GMP compliance at the Drug Product IMP production facility in Basel.

The ideal candidate:

Holds a Master's degree in natural sciences with more than 10 years of professional experience in the pharmaceutical industry, of which at least 5 years are in Quality Assurance. The person has knowledge of cGMP and quality requirements for clinical development phases, as well as a proven track record of success in inspections. Good IT skills, as well as fluent German and English skills.

Tasks & Responsibilities:

* Release of raw materials
* Review and release of documents such as: specifications, risk assessments, deviation reports and Change Control records, method validations
* Collaboration with contract laboratories
* Support of the assigned departments regarding GMP-relevant issues
* Conducting self-inspections
* Support during authority inspections
* QA oversight for laboratory equipment and analytical instruments (deviations, changes)
* QA oversight for CSV of simple systems (GAMP5 Category 1 and 3), e.g., review and approval of Periodic Reviews

Must-haves:

* Completed degree in natural sciences, at least at the Master's level
* At least 10 years of professional experience in the pharmaceutical industry, with at least 5 years in Quality Assurance
* Knowledge of cGMP and quality requirements for clinical development phases
* Proven track record of success in inspections by health authorities and internal GMP audits
* Knowledge of laboratory equipment and analytical instruments (structure, function, requirements, etc.)
* Basic CSV experience (GAMP5)
* Good IT skills (MS Office) - especially experience with SAP, as well as other quality management systems (e.g., Veeva Vault)
* Fluent written and spoken German and English skills

Nice to Haves:

* Professional experience in the field of pharmaceutical development (Synthetic Molecules Drug Product)
* Experience in QA oversight of qualifications and validations (Eudralex Vol.4 Annex 15/ Annex 11)

Sounds interesting? Apply Now! We look forward to receiving your application.

Application Submission Deadline: 12.03.2026

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