Senior Quality Assurance Specialist

We are seeking a passionate Senior QA specialist. You will be a part of the well-functioning QA Drug Substance/QA for QC team in the QA Commercial Operations department, with responsibility for quality oversight of starting materials, intermediates, and Drug Substances for commercial products. Key Responsibilities

• Ensure oversight of outsourced activities in collaboration with the CMC and Manufacturing team
• Advisor and support for internal CMC and Manufacturing team
• Ensure traceability and compliance of CMC documentation
• Maintenance of the supplier program in collaboration with stakeholders
• Support in qualification of new vendors and service providers
• Coordinate and conduct GMP audits of CDMOs, testing laboratories and suppliers
• Coordinate and conduct internal audits/self-inspections
• Perform internal training in e.g. GMP and internal procedures
• Creates, reviews and approves CDMO/supplier quality agreements
• Monitor performance through KPIs and quality metrics
• Oversee and manage internal and external deviations, CAPAs, and change controls
• Participates in QMS continuous improvement, eDMS and eQMS implementations, problem-solving and corrective actions
• Writes/reviews/approves SOPs/other documentation
• QA review and approval of master and executed batch records, protocols and reports, specifications etc.
• Support regulatory inspections and audit readiness activities
• Monitoring of evolving regulations and guidelines

Experience:

• 10+ years of pharmaceutical/biotech QA experience
• Direct experience managing quality oversight of CDMOs in a clinical-stage environment
• Working knowledge of GMP regulations