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Serve as the primary quality contact for all communications related to drug substance and drug product PPQ
Review and approve PPQ documentation including protocols, reports and discrepancies
Review executed PPQ batch records and ensure accurate transcription into reports
Ensure discrepancies during execution are fully investigated and assessed for PPQ impact
Participate in FMEA and other risk-based activities to evaluate process performance
Provide regular updates on PPQ progress and escalate delays, failures or issues in a timely way
Act as the main quality representative in project teams, escalating when needed and ensuring cross-functional alignment
Occasional travel may be required

Competences:

Experience in Quality or Process Validation
Strong GMP knowledge, especially for small molecule drug substance and drug product operations
Skilled in managing multiple priorities in a fast-paced environment
Experience collaborating with CMC, regulatory, MSAT and other quality functions across countries and time zones
Strong ability to evaluate quality risks and propose mitigation strategies
BSc in a relevant scientific discipline
Strong PC skills including MS Office

Quality Manager