Global Quality Manager – Quality Assurance (GMP/GDP)

About the role

We are seeking a highly motivated Global Quality Manager to lead quality assurance activities for a Basel‑based customer. The role ensures product quality and regulatory compliance across worldwide clinical trials, providing expert guidance on GxP processes and supply‑chain distribution.

Key responsibilities

• Act as Delegate of the Swiss Responsible Person, making final quality decisions and ensuring regulatory compliance.
• Maintain global QA oversight and drive the deviation management process, including product impact assessments and CAPA review.
• Own the lifecycle of quality documentation and change records, establishing, reviewing and approving internal and external procedures.
• Lead inspection and audit activities for all GxP inspections, supporting health‑authority interactions.
• Manage temperature excursion events and coordinate expert statements/opinions.

Required profile

• Bachelor’s degree in a scientific or technical discipline (e.g., Pharmacy, Chemistry, Biology, Engineering).
• Minimum three years of quality assurance experience with a strong focus on compliance.
• Deep knowledge of regulated GxP environments (GMP/GDP).
• Fluent written and spoken English; German is a plus.

Required skills

• GMP and GDP compliance.
• Deviation management and CAPA processes.
• Temperature excursion management.
• Quality documentation and change‑record lifecycle.
• Inspection and audit coordination.
• Familiarity with Veeva Vault QMS (nice to have).
• PTQ experience (nice to have).
• Supplier and depot management.