QA GCP Director, R&D Quality

Orchard Therapeutics ,
London, Greater London
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Job Description

Location: London, England Reporting to: Senior Director, R&D Quality Job summary Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Orchard is in an exciting start-up phase where a Quality Assurance (QA) professional can have a real impact on the work and foundations that are being created. This role will report to the Sr Director, R&D Quality located in London, England and will be responsible for providing Quality and Compliance support to and working with Orchards GCP teams. In addition, the candidate will also be the company named archivist ensuring the secure retention of all functional clinical trial documents and materials. We are seeking a candidate with outstanding Good Clinical Practice (GCP) knowledge, excellent audit skills of investigator sites, vendors and internal processes including Inspection readiness activities, communication, and facilitation skills, and the ability to manage multiple projects. Requirements * Be the reference QA GCP person. * Manage the GCP related day to day activities of the QA department. * Providing day-to-day GCP advice and support to the Clinical trials teams. Working closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement. Manages multiple GCP projects and ensures overall and timely completion of tasks. * Leads the development of risk-based annual audit strategies for GCP. * Leads and manage all GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors. Escalate signals identified to risk of business continuity due to any GCP quality issue. * Trains and manages contracts auditors. * Leads in readiness preparation, and directly support regulatory agency inspections. * Lead and manage the coordination of the response to any findings. * Leads intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation). * Evaluate, write and/or review operating procedures (e.g. SOPs), and perform other activities in support of an integrated cross-functional quality management system (QMS). * Manages the implementation, management and maintaining control of record management processes, including the Trial Master File (TMF) and associated ancillary systems to ensure compliance with regulations. * Organizes and provides TMF and associated ancillary systems process implementation and associated training and guidance to functional areas. * Ensures inspection readiness for essential documentation, materials and records for inspection by regulatory agencies. * Provides input to CRO project plans and contracts relevant to GCP records management systems to ensure high quality study set up, TMF set-up, management and archiving * Actively participates in team/CRO/vendor meetings relevant to records management and discusses TMF and ancillary records status of each study. Required knowledge * 10+ years GCP QA compliance experience, including extensive hands-on execution of GCP audits (internal, vendor and Investigator site audits). * 6+ years GCP regulatory inspection management experience and demonstrated management of audit teams. * 3+ years of people management experience. * Expert in GCP regulations and a recognized expert resource on a range of clinical compliance topics. * Good understanding of the regulations of Advanced Therapy Medicinal Products (ATMPs) in the EU and Regenerative Medicine Advanced Therapies (RMATs) in the US is a plus. * Expertise in compliance with respect to pharmaceutical/biologics Quality Risk management and analytics. * Willingness/availability to travel up to 25-30% (including international travel). Skills & Abilities * Excellent written and verbal communication skills. * Strong interpersonal skills and the ability to work well as part of a team. * Proficient in Microsoft Office suite. * Excellent organization skills and project management. * A resilient and visionary Quality Professional willing to pave a path. * Archivist experience preferred, but not essential. Education * Bachelors Degree required Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred. Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. Notice to All Applicants: Orchard Therapeutics participates in E-Verify RECRUITERS All employment offers and CVs are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard

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