Technical QA Manager (60-80%)

Thr IMP Quality Systems and Qualification/Validation team plays a key role in ensuring GMP compliance of facilities and systems used for the manufacture of Investigational Medicinal Products (IMPs). The team covers production facilities for the chemical synthesis of small molecules and nucleotides, solid dosage formulation, sterile filling, packaging and analytics, and CSV systems. We are looking for someone who can provide technical QA oversight and contribute to maintaining the highest quality standards.




General Information:
 

• Start date: as soon as possible
• Latest start date: 01.12.2025
• Planned duration: until end of 2029
• Contract: temporary via Randstad
• Workplace: Basel
• Workload: 60-80%
• Home Office: possible upon discussion
• Working hours: Standard

Tasks & Responsibilities:
 

• QA oversight of qualification and validation activities for GMP-relevant facilities and systems in drug substance and/or drug product manufacturing.
• QA oversight of CSV systems.
• 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 resolve 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 sciences, pharmacy, or comparable
• Fluent in German and English
• At least 5 years of professional experience in the pharmaceutical industry, including at least 2 years in quality assurance
• At least 3 years of experience in facility qualification/validation
• Understanding of current data integrity (DI) requirements
• Knowledge of global quality and GMP requirements
• Proven success in inspections by health authorities and internal GMP audits
• Strong team player with excellent communication and influence skills

Nice to Haves:
 

• Experience in sterile and/or low-germ manufacturing of pharmaceuticals
• Experience in the analysis of synthetic molecules and drug products
• Experience with Veeva QMS, eVAL, and ELVIS