Director, GCP, GVP, GLP QA

Orchard Therapeutics; Greater London; On-site; GBP 100,000 - 140,000; Full time

Job summary

A global biopharmaceutical company in Greater London is seeking a Director for GCP, GVP, & GLP QA. This role involves strategic oversight for compliance activities, managing regulatory inspections, and driving continuous improvement in the Quality System. The ideal candidate has a scientific background with over 10 years of relevant experience, strong people management skills, and expert knowledge in regulatory compliance. This key leadership position ensures that all development activities comply with global regulations and maintains inspection readiness.

Qualifications

• 10+ years of pharmaceutical/biotechnology drug development experience with at least 10 years in GCP, GVP, and GLP QA compliance.
• In-depth knowledge of GCP, GLP, and GVP regulations and ICH guidelines.
• Proven track record of strong people management.

Responsibilities

• Provide overall strategic oversight for GCP, GVP, & GLP QA activities.
• Lead and provide technical direction for Health Authority inspections.
• Drive continuous improvement of the Quality System.

Skills

Expert-level knowledge in GCP, GVP, and GLP compliance

Outstanding communication skills

Strong risk management expertise

Proven people management skills

Education

Bachelor’s degree in a scientific field

Job description

Overview

Location: London

Reporting to: Vice President, Global Quality

Job Summary

Reporting to the Vice President, Global Quality, the Director, GCP, GVP, & GLP QA is a key leadership role responsible for establishing and executing the strategy for GCP, GVP, & GLP compliance.

This leader will drive the continuous improvement of the Quality System and ensure all research, clinical (GCP), and non-clinical (GLP) development activities, as well as pharmacovigilance (GVP), are conducted in full compliance with global regulations. This role provides critical quality oversight, manages regulatory agency inspections, and ensures a state of inspection readiness across all relevant functions.

Key Elements and Responsibilities :

• Strategic Leadership: Provide overall strategic oversight for global GCP, GVP, & GLP QA activities, ensuring collaborative and compliant implementation of initiatives with all internal and external partners.
• Stakeholder Partnership: Act as a senior strategic partner to Clinical Development, Pharmacovigilance, and Non-Clinical leadership. Provide expert counsel and effectively influence senior stakeholders to navigate complex compliance challenges.
• Inspection & Audit Oversight
• 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 (e.g., CROs), and oversee the execution of the comprehensive audit program.
• Quality System & Continuous Improvement
• 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.
• Risk Management & Business Continuity
• Implement risk-based quality approaches for clinical development programs and provide ongoing quality risk monitoring.
• Raise early signals to leadership regarding any GCP, GVP, or GLP quality issues that pose a risk to business continuity and provide clear direction on mitigation measures.
• Regulatory Intelligence: Monitor major regulatory updates and industry trends, benchmarking through professional consortia and networking to identify and lead necessary change management opportunities.

Requirements

Required Knowledge & Skills :

• 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.