Quality Assurance Manager (a)

• Ensure compliance with regulatory standards and company policies in the LIFE SCIENCES industry.
• Review and approve all PPQ related documentation (protocols, reports, discrepancies, etc.).
• Review executed PPQ batch records and ensure accurate transcription to reports
• Ensure any execution discrepancies are properly investigated and impact to PPQ is assessed
• Participate in FMEA or other risk-based approaches to assess process performance
• Provide regular updates on PPQ progress and escalate challenges (PPQ failures, delays), timely
• Act as main quality contact on project teams, escalating as appropriate and seeking cross functional alignment and clarifications as needed to ensure product quality.

• Degree in a relevant field, such as Life Sciences or a related discipline.
• 3-5 years of experience in Quality / Process Validation
• Strong knowledge of Good Manufacturing Practices (GMP), specifically for small molecule drug substance and drug product operations
• Ability to effectively manage time, multiple overlapping priorities and progress tasks to meet timeline in a fast pace/dynamic environment.
• Experience working cross-department with CMC, regulatory, MSAT and other quality functions across multiple countries / time zones
• Ability to evaluate and understands quality risk, including risk mitigation
• Business fluency in English

Our client offers you:

• An opportunity to contribute to impactful projects in the LIFE SCIENCES industry.
• A collaborative and professional work environment in BASEL with a hybrid work option
• Comprehensive onboarding and training for a seamless start.
• Access to resources and tools to support your professional development