Head of Quality Control

About the role

The Head of Quality Control will provide scientific leadership for analytical quality activities across the product lifecycle of an innovative pharmaceutical organization. This strategic, cross‑functional role ensures robust analytical control strategies, regulatory readiness, and successful project execution.

Key responsibilities

• Provide scientific oversight of analytical activities performed by Contract Manufacturing Organizations (CMOs).
• Critically review analytical data, Out‑of‑Specification (OOS) and Out‑of‑Trend (OOT) investigations, and change‑control documentation.
• Develop and implement analytical control strategies throughout the product lifecycle.
• Align QC activities with project timelines and regulatory milestones.
• Collaborate with cross‑functional teams to integrate analytical considerations into development plans.
• Participate in risk assessments, including nitrosamines, elemental impurities, and impurity control strategies.
• Contribute to stability study design and evaluation in accordance with ICH guidelines.
• Support analytical method transfers, validation activities, and onboarding of new CMO partners.
• Provide analytical input for regulatory submissions and post‑approval changes.
• Serve as a technical advisor on QC‑related matters to Regulatory Affairs, MSAT, Project Management, and Leadership teams.
• Travel occasionally (5–10%) to CMO sites for technical discussions, investigations, and troubleshooting.

Required profile

• Minimum 8 years of experience in pharmaceutical Quality Control or analytical development.
• At least 4 years working within matrixed, project‑driven organizations.
• Full professional proficiency in English; German or French advantageous.

Required skills

• Analytical method transfer and validation.
• Oversight of outsourced analytical activities through CMO partnerships.
• Small‑molecule analytical control (biologics experience advantageous).
• Experience with sterile pharmaceutical products.
• Risk assessment for nitrosamines, elemental impurities, and impurity control.
• Stability study design and evaluation per ICH guidelines.