Director, GCP, GVP, GLP QA

19 hours ago

City Of London, United Kingdom Orchard Therapeutics - U.S. Full time

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. Audit Strategy Development: 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 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. Seniority level: Director Employment type: Full-time Job function: Other #J-18808-Ljbffr

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