On behalf of our client, a global biopharmaceutical company (focus on oncology) headquartered in the Basel area and currently having more than 11,000 employees worldwide, we are seeking, starting immediately and for an expected term until 03 July 2026 (as may be extended) a “Quality Manager (100%; Contractor)”. The draft JD reads as follows (with minor adjustments from us):

Responsibilities

• Reporting to the Senior Director CMO Management and Commercial Product Quality (based in the US), be part of a cross-functional, international project team commercializing a new product at 2 European CMOs and serve as the primary point of contact for all quality-related communications pertaining to the drug substance and drug product Process Performance Qualification (PPQ)
• Review and approve all PPQ related documentations such as, e.g., 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 timely escalate challenges such as, e.g., PPQ failures and/or delays
• Act as main quality contact on project teams, escalating as appropriate and seeking cross-functional alignment and clarifications as needed to ensure product quality

Requirements

• Bachelor (or higher) in a relevant scientific discipline
• At least 5 years of experience in Quality and/or Process Validation. Required is a strong knowledge and experience in Good Manufacturing Practices (GMP) and PPQ relating to small molecule drug substances and drug product operations. Experience in external manufacturing environments would be a plus
• Ability to effectively manage time, multiple overlapping priorities and progress tasks to meet timeline in a fast paced and dynamic environment
• Experience in cross-functional working with CMC, regulatory, MSAT and other quality functions across multiple regions and continents
• Ability to evaluate and understand quality risk, including risk mitigation
• Strong user knowledge of MS Office Suite and other software programmes
• Ability to regular travel within Europe as may be required
• Residence in Switzerland (with Swiss work permit) or a cross-border permit (if residence in Germany or France) are required

Place of work: Greater Basel area (with possibility of working from home)