Senior Quality Control Manager – Biotech

About the role

We are supporting a growing biotech company that is expanding its complex product portfolio. The Senior Quality Control Manager will lead analytical laboratory activities, manage external vendors, and drive cross‑functional projects with a scientific and solution‑oriented approach.

Key responsibilities

• Provide scientific oversight of analytical activities performed by external vendors.
• Assess analytical data, investigate out‑of‑specification/out‑of‑trend results, deviations, and change controls.
• Develop and implement analytical control strategies throughout the product lifecycle.
• Align QC deliverables with project plans, regulatory timelines, and business objectives.
• Collaborate with cross‑functional teams to integrate analytical considerations into overall project strategy.
• Travel to CMO sites as needed to support troubleshooting, technical discussions, and investigations.

Required profile

• 8+ years of experience in Quality Control and analytical development.
• Proven experience with analytical method transfer and validation activities.
• Solid knowledge of GMP and ICH guidelines (Q1, Q2, Q3A/B/C, DMSc).
• PhD or MSc in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related discipline.

Required skills

• Analytical method transfer
• Method validation
• GMP compliance
• ICH Q1, Q2, Q3A/B/C, DMSc knowledge

What we offer

• Competitive salary package
• Diverse and dynamic work environment
• Clear career progression opportunities