Overview
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.
Retribuzione / Benefits annual premio
pension
private medical insurance
wellbeing programme
flexible benefits programme
relocation support
Responsabilità 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
Requisiti fondamentali 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 auditin
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