For our client, a leading global pharmaceutical company in Switzerland, we are looking for a Technical QA Manager.
General Information: ...
- Start date: ASAP
- Latest start date: 01.09.2025
- Planned duration: 12 months, with the possibility of extension
- Workplace: Basel
- Workload: 100%
- Home Office: on-site required, with the option for home office upon request
- Team: 20 People
- Department: Basel Large Molecule DP, Synthetic Molecules (MMQEB)
- Working hours: Standard
About the job:
Our client’s IMP Quality Systems and Qualification/Validation team plays a central role in ensuring GMP compliance of facilities and systems used for the manufacture of investigational medicinal products (IMPs) in Basel and Kaiseraugst. They are looking for someone who can provide technical QA oversight and contribute to maintaining the highest quality standards.
The “perfect candidate” will have more than 10 years of experience in the pharmaceutical industry, including 5 years in quality assurance. They will have experience in the qualification/validation of facilities for the manufacture of synthetic molecules and a deep understanding of current data integrity requirements. They will also be familiar with global quality and GMP requirements and communicate fluently in German and English.
Tasks & responsibilities:
- Monitoring qualification and validation activities for GMP-relevant facilities and systems in the production of synthetic molecules, including CSV.
- Ensuring QA oversight and setting guardrails regarding GMP and quality standards.
- Support the implementation of data integrity requirements.
- Review and approve GMP documents (e.g. qualification plans, reports, change and deviation management, CAPAs, SOPs, risk analyses).
- Conduct in-depth root cause analyses to solve complex problems.
- Drive optimization and improvement activities within IMP Quality
- Collaborate with stakeholders and contribute to the achievement of common goals.
- Represent the area of responsibility during inspections by health authorities and internal audits
- Support end-to-end cGMP activities and maintain the Right to Operate
Must Haves:
- Academic degree in engineering, chemistry, life science, pharmacy or equivalent.
- Extensive experience in the pharmaceutical industry (10+ years), including 5 years in QA
- Experience in facility qualification/validation in the production of synthetic molecules
- Understanding of current data integrity (DI) requirements
- Knowledge of global quality and GMP requirements
- Strong team player with excellent communication and influencing skills
- Proven success in inspections by health authorities and internal GMP audits
- Fluent in German and English (spoken and written)
Nice to haves:
- Experience in sterile and/or low-aseptic manufacturing of medicinal products
- Experience in the analysis of synthetic molecules and drug products
- Experience with QMS administration
If you want to make a significant impact and advance your career, this is an exceptional opportunity. We are looking forward to receiving your application. Apply Now!
Application Submission Deadline: 25.06.2025
