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Location: Basel
Contract duration: 12 months
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.
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:
- Completed scientific studies, at least at Master's level.
- Fluent written and spoken German and English skills
- At least 10 years of professional experience in the pharmaceutical industry, of which at least 5 years in quality assurance.
- Knowledge of cGMP and quality requirements for clinical development phases.
- Proven success in inspections by health authorities and internal GMP audits.
- Good IT skills (MS Office) - especially the handling of SAP, as well as other quality management systems (e.g. Veeva Vault).
