Senior R&D QA Lead - GCP & Inspection Readiness

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).

Responsibilities

• Oversee compliance with protocols and regulatory guidance.
• Develop and execute study audit plans.
• Manage site-level inspections and oversee inspection-related CAPAs.

Skills

GCP Quality Assurance

Clinical trial oversight

Risk management

Auditing

Communication skills

Education

Advanced degree in life sciences or related field

Job description

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.