Technical QA Manager (m/f/d)

Contract duration: 12 months/possible extension

The IMP Quality Systems and Qualification/Validation team plays a central role in ensuring GMP compliance of facilities and systems used for the production of investigational medicinal products (IMPs) in Basel and Kaiseraugst. We are looking for someone who can take on technical QA oversight and contribute to maintaining the highest quality standards.

Responsibilities:

• Supervision of qualification and validation activities for GMP-relevant equipment and systems in the production of synthetic molecules, including CSV.
• Ensure QA oversight and establish guidelines regarding GMP and quality standards.
• Support the implementation of data integrity requirements.
• Review and approval of GMP documents (e.g. qualification plans, reports, change and deviation management, CAPAs, SOPs, risk analyses).
• Perform in-depth root cause analysis to solve complex problems.
• Driving optimization and improvement activities within IMP Quality
• Collaborate with stakeholders and contribute to the achievement of common goals.
• Representing the area of responsibility during inspections by health authorities and internal audits
• Supporting end-to-end cGMP activities and maintaining the right to operate

Requirements:

• Academic degree in engineering, chemistry, life science, pharmacy or equivalent
• Fluent in German and English (spoken and written)
• Extensive experience in the pharmaceutical industry (10+ years), including 5 years in QA
• Experience in plant 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 influence skills
• Proven success in inspections by health authorities and internal GMP audits