Quality Assurance Manager Drug Product

Quality Assurance Manager Drug Product m / f / d, Basel-Stadt

As part of the Synthetic Molecules IMP Quality Group, the QA Manager plays a key role in ensuring robust quality oversight for Synthetic Molecules Drug Substance and Drug Product operations, including associated quality control activities. Embedded within the IMP Quality Organisation Switzerland, this position is responsible for safeguarding GMP compliance and driving continuous quality improvement at the Drug Product IMP manufacturing facility at the Basel site.

The ideal candidate holds a Master's degree in a scientific discipline and brings over 10 years of experience in the pharmaceutical industry, including a minimum of 5 years in Quality Assurance. A strong understanding of cGMP requirements and quality standards across clinical development phases is essential, along with a proven track record of successfully supporting regulatory inspections.

Fluency in both German and English is mandatory

Location : Basel

Contract duration : 12 months

Responsibilities :

• Review of Drug Product Batch Records, in cooperation with the relevant departments.
• Implementation of the IMP Drug Product release.
• Review and release of documents such as : specifications, risk assessments, deviation reports and change control records.
• Review and approval of cleaning protocols and reports.
• Support of the supervised departments with GMP-relevant issues.
• Conducting self-inspections.

Requirements :

Sounds like a great job?

Then we look forward to receiving your complete application documents through our online application form.

When applying by email, the sender agrees that his or her data will be used in accordance with our data privacy policy.

Find more vacancies at : coopers.ch