Direct message the job poster from Nexia

Position Summary

The GCP Audit Lead will plan and conduct GCP audits of company processes, systems, facilities, studies and documents, including electronic records/computer system validation documents, to ensure compliance throughout the organisation, as well as across external vendors and service providers.

The role will act as a key link between Corporate Quality and GCP Quality, supporting stakeholders in maintaining SOP compliance, resolving non-conformance and CAPA, and ensuring readiness for inspections. The role will also lead projects and initiatives that drive inspection readiness and continuous quality improvements across global functions.

The successful candidate will work closely with R&D, Clinical Operations and Global Quality to drive improvements, ensure efficiency of processes supporting GCP compliance, and assess/implement changes to ensure GMP-based processes and systems (e.g. manufacturing and release of IMPs) are fit for use in clinical studies.

Key Responsibilities

• Develop internal and external GCP audit schedules via risk assessment.
• Support the vendor approval process for GCP and GCLP vendors through audit, questionnaire, document review or risk assessment, including qualification of electronic solutions (e.g. eDiary, data management processes, apps).
• Organise, conduct, report and follow up on GCP, GPvP and GCLP audits as part of the company’s audit programme.
• Collaborate closely with Clinical functions to ensure SOP compliance and GCP excellence.
• Manage CAPA processes, including monitoring effectiveness checks.
• Work cross-functionally to follow up and close out audits, ensuring appropriateness of corrective actions.
• Liaise with internal and external stakeholders globally.
• Provide operational support during clinical quality investigations and potential critical GCP breaches to ensure regulatory reporting timelines are met.
• Supply KPIs and relevant updates at Clinical Quality Council.
• Align working practice compliance across UK, German and Spanish offices to avoid discrepancies.
• Maintain up-to-date knowledge of current legislation and provide regular briefings/training.
• Promote compliance with GCP and foster a strong Quality Culture across the business.
• Demonstrate and promote company values and behaviours.

Minimum Qualifications & Experience

• Significant experience in the pharmaceutical/biopharmaceutical industry, ideally with a background in Quality Auditing or Clinical Operations (e.g. QA/Auditing/CRA).
• Proven experience leading GCP, GPvP and GCLP audits.
• Strong skills in MS Word, Excel and/or Access, with ability to process and present data graphically.
• Excellent report writing and communication skills.
• Strong knowledge of drug development processes.
• In-depth knowledge of GCP regulations and standards across EU, UK and US.
• Working knowledge of GPvP, GCLP and CSV requirements.
• Experience in auditing electronic solutions (e.g. eDiary, data management systems, apps).
• Excellent attention to detail.
• MSc in Life Science (or equivalent).
• Willingness and ability to travel.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance, Science, and Research
• Industries: Pharmaceutical Manufacturing, Medical Practices, and Biotechnology Research