Senior Manager, R&D Quality Assurance (GCP)

Proclinical Staffing; England; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

A leading life sciences recruitment agency is seeking a Senior Manager, R&D Quality Assurance to oversee clinical quality compliance for clinical studies. The role involves leading audit activities, ensuring adherence to GCP standards, and managing inspection readiness efforts. The ideal candidate will have a strong background in life sciences, proven GCP experience, and excellent communication skills. This position offers a hybrid working model based in Maidenhead, UK.

Qualifications

• Proven experience in GCP Quality Assurance and clinical trial oversight.
• Expertise in managing late-phase clinical trials and leading audits.
• Strong knowledge of GCP regulations and industry guidance (e.g., FDA, EMA).
• Involvement in regulatory inspections and inspection readiness.
• Strong knowledge of GCP regulations (FDA/EMA).
• Familiarity with QA functions: auditing, regulatory affairs, data management.

Responsibilities

• Oversee compliance with protocols and regulatory guidance.
• Develop and execute study audit plans.
• Manage site-level inspections and oversee inspection-related CAPAs.
• Address non-compliance through investigations and corrective actions.
• Guide junior QA staff and collaborate with internal and external partners.
• Drive inspection readiness and prepare for regulatory inspections.
• Manage site inspections and CAPAs; oversee quality events.
• Support vendor quality oversight including audits and CAPA reviews.
• Participate in process audits and updates to QA tools/SOPs.

Skills

GCP Quality Assurance

Clinical trial oversight

Risk management

Auditing

Communication skills

Communication

Education

Advanced degree in life sciences or related field

Job description

Senior Manager, R&D Quality Assurance (GCP)

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. The 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 have questions, please contact Josh Godden at [e-mail].

Apply Now:

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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Science

Industries

• Professional Services