Director of GMP Quality Operations

About the role

We are seeking a senior quality leader to provide GMP oversight for a global network of external manufacturers supporting late‑stage clinical development and regulatory submissions. The role combines on‑site QA leadership at CDMOs with strategic quality management across the organization.

Key responsibilities

• Lead GMP quality oversight for drug substance and drug product manufacturing at global CDMOs.
• Act as the on‑site QA lead during manufacturing campaigns, making quality decisions and resolving issues.
• Review and approve batch documentation, investigations, analytical data and support batch release and regulatory filings.
• Partner with Qualified Persons to ensure certification and inspection‑ready documentation.
• Oversee deviations, OOS/OOT investigations, root‑cause analyses and CAPA implementation.
• Provide QA oversight for technology transfer, process validation (PPQ), scale‑up and commercial readiness.
• Manage GMP change controls and assess regulatory impact across manufacturing and testing.
• Collaborate with Technical Operations, Regulatory Affairs and Supply Chain to drive program execution and risk management.

Required profile

• Bachelor’s degree in Life Sciences, Chemistry, Engineering or related field (advanced degree preferred).
• 12+ years of GMP Quality Operations experience in pharma/biotech.
• Proven experience supporting Phase 2/3 clinical programs, registrational manufacturing and NDA/MAA readiness.
• Extensive background in CDMO oversight, validation and inspection preparedness.
• Experience with small‑molecule drug substance and product manufacturing, including sterile injectables and solid oral dosage forms.

Required skills

• GMP compliance and quality systems
• CDMO oversight
• Process validation (PPQ)
• Technology transfer
• Change control management
• Regulatory submission support
• Batch documentation review
• Investigation and root‑cause analysis
• CAPA implementation
• Sterile injectable manufacturing
• Solid oral dosage manufacturing

What we offer

• Competitive remuneration package including equity.
• Dynamic high‑potential start‑up environment.
• Travel opportunities across Europe and Asia (≈50% travel).