Senior QA Expert (m/w/d)

Tasks :

• Manage and maintain QA activities to ensure GMP compliance in sterile manufacturing
• Act as the QA single point of contact for assigned activities
• Author, review, and approve quality documents (e.g., SOPs, risk and gap assessments, WIs)
• Coordinate and approve quality records (deviations, CAPAs, change controls, validation/qualification docs) in TrackWise and KNEAT
• Provide QA oversight for manufacturing processes and activities
• Support investigations, including root cause analysis and implementation of action plans
• Contribute to continuous improvement and lean projects
• Support growth projects in alignment with cGMP requirements
• Monitor project progress and ensure effective communication of status
• Collaborate with internal teams and external partners on quality and release strategies
• Participate in audits and inspections (internal and external)
• Define, track, and report quality KPIs
• Maintain and improve QA oversight concepts within manufacturing
• Support QA activities across the drug product network
• Foster a high-performance, collaborative team environment
• Onboard and support new team members
• Deputize QA Team Lead when required

Qualification:

• Master’s or PhD in Chemistry, Biology, Pharmacy, or related field

• 5–10 years of experience in QA/QC in pharmaceutical manufacturing

• Excellent problem-solving, planning, and organizational skills
• Strong teamwork and a customer-focused mindset
• Strong knowledge of cGMP and regulatory compliance
• Fluent in English; German is an advantage

Start : ASAP