Hybrid Director, GCP, QA

at Orchard Therapeutics

• Job title: Director, GCP, QA
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, London, United Kingdom

About the role

• Director responsible for establishing and executing strategy for GCP, GVP, & GLP compliance oversight. Driving continuous improvement and ensuring compliance with global regulations in London.

Responsibilities

• Provide overall strategic oversight for global GCP, GVP, & GLP QA activities, ensuring collaborative and compliant implementation of initiatives with all internal and external partners.
• Act as a senior strategic partner to Clinical Development, Pharmacovigilance, and Non-Clinical leadership.
• Lead and provide technical direction for all Health Authority inspections (GCP, GVP, GLP), including preparation, hosting, and ensuring robust and timely responses to any findings.
• Develop and execute the risk-based GCP/GVP/GLP audit strategy for all internal processes, investigator sites, and external service providers, and oversee the execution of the comprehensive audit program.
• Drive continuous improvement by leveraging QMS data, monitoring KPIs, and analysing risk.
• Oversee the CAPA process to ensure effective solutions and maintain all GCP/GVP/GLP QA processes, standards, and the associated compliance training program.
• Implement risk-based quality approaches for clinical development programs and provide ongoing quality risk monitoring.
• Monitor major regulatory updates and industry trends, benchmarking through professional consortia and networking to identify and lead necessary change management opportunities.

Requirements

• Bachelor’s degree in a scientific field.
• Minimum 10 years of pharmaceutical/biotechnology drug development experience, with at least 10 years in GCP, GVP, and GLP QA compliance.
• Expert-level knowledge in leading Health Authority inspections (GCP, GVP, GLP) and managing global, risk-based audit programs.
• In-depth, applied knowledge of applicable GCP, GLP, and GVP regulations and ICH guidelines.
• Proven track record of strong people management and the ability to build and develop a high-performing team.
• Outstanding communication, presentation, and influencing skills, with a demonstrated ability to hold senior leaders accountable and navigate complex problems.
• Strong risk management expertise, including issue identification, problem-solving, and decision-making.
• Working knowledge of all Clinical Development phases and processes.