QA GMP Senior Auditor

In this role you will support the execution of audits (second and first party), qualify R&D suppliers, and manage Quality Agreements to ensure GMP compliance for sterile, biological, and biotech products. You will collaborate with cross-functional teams and external consultants to drive quality assurance across supplier networks. The position offers hands-on audits, KPI data review, and SOP standardisation within a performance-driven, global R&D context. This is a chance to contribute to high-stakes compliance in gene therapies and advanced platforms.

• annual bonus
• pension
• private medical insurance
• wellbeing programme
• flexible benefits programme
• relocation support

• Plan and execute second party audits of GMP suppliers and GMP service providers (CMOs, contract laboratories)
• Execute first party audits
• Monitor corrective and preventive actions and ensure timely closure
• Coordinate external consultants supporting Auditing & Supplier Qualification - GMP & Medical Device Unit
• Define, review and finalise Quality Agreements with GMP suppliers and service providers
• Support hosting of GMP inspections
• Collect and review data for Management Review and KPIs/metrics
• Finalize and standardise SOPs related to auditing and supplier qualification processes
• Organise and support training on GMP requirements and related procedures
• Act as QA reference for audit and qualification activities involving sterile, biological and biotech products
• Interact with CMC, Regulatory Affairs, Clinical Supply, Procurement and cross-functional teams to qualify providers

• Scientific degree, preferably in Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or related discipline
• At least three years of experience as auditor in pharmaceutical companies
• Experience in Quality Assurance, supplier qualification or audit activities within pharmaceutical development or manufacturing
• Knowledge of GMP requirements
• Knowledge of auditing techniques
• Knowledge of sterility assurance principles and GMP expectations for sterile and biotech products

• Leadership
• Organisational skills
• Stress management
• Knowledge of GMP requirements
• Auditing techniques
• Sterility assurance principles