Proclinical is seeking a Senior Manager, R&D Quality Assurance (GCP) to provide clinical quality oversight for assigned clinical studies. In this role, you will ensure compliance with protocols, international and local regulations, and Good Clinical Practice (GCP) standards. You will lead inspection readiness efforts, support audit activities, and contribute to quality assurance initiatives. This position offers a hybrid working model based in Maidenhead, UK.
Responsibilities:
- Act as the QA Program Lead, overseeing compliance with protocols, company SOPs, GCP, and regulatory guidance.
- Develop and execute study audit plans, including investigator site audits, audit reports, and corrective/preventive action plans.
- Lead quality activities for late-phase clinical trials, focusing on risk management and endpoint de-risking.
- Address compliance issues, including sponsor, clinical site, and vendor non-compliance, through investigations and corrective actions.
- Provide guidance to junior QA staff and collaborate with internal teams and external partners.
- Drive inspection readiness efforts, including creating workstreams and preparing for regulatory inspections.
- Manage site-level inspections and oversee inspection-related CAPAs and quality events.
- Support vendor quality oversight, including vendor audits and CAPA reviews.
- Participate in process audits, process improvement initiatives, and updates to QA tools and SOPs.
- Stay updated on local and international GCP requirements and developments.
- Travel as required (approximately 10-25%).
Key Skills and Requirements:
- Background in life sciences, technology, pharmacy, or a related field; advanced degree preferred.
- Proven experience in GCP Quality Assurance and clinical trial oversight.
- Expertise in managing late-phase clinical trials and leading audits.
- Experience in inspection readiness and direct involvement in regulatory inspections.
- Strong knowledge of GCP regulations and industry guidance (e.g., FDA, EMA).
- Familiarity with various QA functions, including auditing, clinical operations, regulatory affairs, and data management.
- Excellent communication and collaboration skills.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.
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