QA Manager

About the role

We are seeking an experienced QA Manager to provide GMP/GDP quality assurance expertise for the development and commercialization of pharmaceutical products for our client in Allschwil.

Key responsibilities

• Provide GMP/GDP quality assurance throughout product development, ensuring all quality activities are initiated and completed according to the development stage.
• Guide resolution of complaints, testing issues, deviations, OOS investigations and propose CAPA actions.
• Establish quality risk management using Six Sigma concepts and ensure stakeholder alignment across the product life‑cycle.
• Support release of active ingredients and medicinal products, including master process documentation approval, batch record review and change control assessment.
• Prepare GMP/GDP agreements with CMOs, write/review SOPs and contribute to optimisation of the pharmaceutical quality system.

Required profile

• University degree (master level minimum) in Pharmacy, Chemistry or related technical/science field.
• 3‑6 years of experience in pharmaceutical product development, quality control, analytical development or chemical production.
• 3‑6 years of QA experience with drug substance and/or drug product, strong knowledge of (c)GMP/GDP.
• Ability to manage complex projects, prioritize workload and lead quality activities proactively.
• Fluent English; basic German or French is advantageous.

Required skills

• GMP/GDP compliance
• Six Sigma methodology
• CAPA management
• CMC documentation
• SOP development and review