Global GCP QA Operations Leader

Proclinical Staffing; Greater London; On-site; GBP 95,000 - 130,000; Full time

Job summary

Proclinical is seeking a Senior Manager, GCP QA Operations in London to drive quality across global clinical development programmes. You will provide expert QA guidance to stakeholders, ensuring GCP compliance and readiness for inspections, while promoting a culture of continuous improvement.

The role requires aMaster's degree (Quality or PhD preferred), strong leadership, and the ability to work across functions in a matrixed organization. Up to 20% travel is anticipated.

Qualifications

• Master's degree or higher in a relevant scientific field is essential.
• Degree in Quality or a PhD is preferred.

Responsibilities

• Ensure compliance with GCP and regulatory requirements for studies and programs.
• Provide quality oversight and ensure consistent operational methodologies.
• Act as a partner to cross-functional study teams, offering QA guidance.
• Monitor quality performance and promote best practices.
• Review quality agreements and contracts with vendors for compliance.
• Support clinical quality plans and risk-based approaches; assist inspections.
• Collaborate with stakeholders to address issues and implement CAPA.
• Facilitate continuous improvement of clinical and quality systems.
• Conduct risk assessments and manage quality events and investigations.
• Communicate corporate quality objectives for clinical research.
• Promote continuous process improvement and quality risk management.

Skills

GCP QA

GVP

GPP

Quality systems

Stakeholder mgmt

English fluency

Education

Master's degree

Quality degree

PhD preferred

Job description

Proclinical is seeking a Senior Manager, GCP QA Operations in London to drive quality across global clinical development programmes. You will provide expert QA guidance to stakeholders, ensuring GCP compliance and readiness for inspections, while promoting a culture of continuous improvement.

The role requires aMaster's degree (Quality or PhD preferred), strong leadership, and the ability to work across functions in a matrixed organization. Up to 20% travel is anticipated.