Orchard Therapeutics

QA Engineer

• 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.

Director, GCP, QA

Compliance

• Serve as US Regulatory Science subject matter expert and senior advisor to program regulatory teams; define Orchard’s US regulatory strategies across the pipeline.
• Collaborate closely with assigned US Regulatory lead, European peers, Regulatory CMC team and VP of Regulatory Science to ensure consistent global regulatory approaches.
• Lead/oversee preparation and review of meeting requests, briefing documents and strategic regulatory filings; prepare cross-functional teams for meetings and interface with US regulatory authorities (FDA).
• Ensure coherent communications and strong relationships with FDA; anticipate FDA reactions, interpret and assess impact of Agency requests and prepare actionable response plans.
• Lead US regulatory intelligence and regulatory policy activities: monitor, identify, assess, analyze impact and disseminate relevant regulatory updates; participate in industry associations to advocate on US regulation affecting Orchard’s portfolio.
• Hold line management responsibilities; support VP of Regulatory Science in management of Regulatory Science resources and budget across programs and oversight of third-party vendors.
• Ensure team adherence to GxP and Orchard policies/SOPs; participate in regulatory department AOP and budget adherence.
• Monitor program progress, develop contingency plans, and ensure effective cross-functional collaboration with Clinical, Non-Clinical and Tech Ops/CMC departments.
• Participate in business development initiatives when relevant; travel internationally (mostly UK/EU) as required.

Director, GCP, QA

Executive Director, Regulatory Science