Description
*Lead GCP Auditor - UK Remote - Part-Time - 12 month contract*Are you an experienced Auditor interested in joining our biotech client that is leading the way in developing innovative CAR-T cell therapies for cancer treatment?We're hiring for a fast growing clinical-stage bio-pharmaceutical company at an exciting stage of development and would like to appoint a Lead GCP Auditor responsible for planning and delivering the GCP audit programme.Key Responsibilities • Leading, planning, conducting, documenting and follow up activities of global GCP audits of vendors, contract research organizations (CROs), clinical investigator sites, systems, trial master file, and internal processes in accordance with applicable regulations, standards, quality agreements, and guidance documents to determine compliance status and identify compliance risks.• Communicate audit and inspection outcomes effectively to key stakeholders. Monitor timely completion of the agreed corrective and preventive actions. Compile metrics, measure trends and identify improvements.• Contribute to upskilling of trainee auditors in the conduct of the above audits. Act as trainer and mentor for GCP Auditors.• Works with contract personnel or consultants to prepare, conduct and report outsourced audits.• Develop and implement risk-based audit plans for GCP regulated activities.• Lead directed (For Cause) audits.• Maintains and updates the audit management system in a timely manner and ensures audit documentation is filed.• 25-40% global travel and ability to conduct remote audits.Experience • Experience in conducting and leading internal and external GCP audits.• Experience in conducting a range of vendor audits (e.g., full service CRO, biostatistics, data management, laboratories).• Expert knowledge of national and international GCP legislation and guidelines.• Current knowledge of regulations, standards, guidance documents, industry initiatives and trend that impact GCP.If you're interested and would like to find out more, reach out on LinkedIn or send your CV to [email protected]