Senior Manager, GCP Quality Assurance (Early-Stage Clinical Development)

Orchard Therapeutics ,
London, Greater London
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Job Description

Location: London, United Kingdom Reporting to: Senior Director, R&D Quality The Company: Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically-modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. With a commercial product already, the company has one of the deepest gene therapy pipelines in the industry and is advancing seven clinical-stage programs across multiple therapeutic areas, including inherited neurometabolic disorders, primary immune deficiencies and blood disorders, where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist. Orchard has offices across the US and Europe, including London, Boston and San Francisco. For more information, please visit www.orchard-tx.com, and follow us on Twitter and LinkedIn. The Role: Despite having a commercial product and Orchard is in an exciting start-up phase where a Quality Assurance 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 early-stage clinical development 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 strong Good Clinical Practice (GCP) knowledge, audit skills, communication, and facilitation skills, and the ability to manage multiple projects. Responsibilities * Serve as Clinical Compliance Lead for assigned clinical trial programs. * Handles multiple projects and ensures overall and timely completion of tasks. * Leads development of audit plan for assigned projects and manages audit plan execution. * Manages and/or leads GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors. * Trains and manages contracts auditors. * Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement. * Assists in readiness preparation, and/or directly support regulatory agency inspection. Assist in coordination of 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 Requirements * BA or BS with relevant industry experience * Substantial previous work experience. * Must have significant GCP audit and compliance experience. Bio-pharmaceutical sponsor experience preferred. * Experience with audit management/CAPA management programs strongly preferred. * Recognized as an expert resource on a range of clinical compliance topics. * Archivist experience preferred, but not essential * Strong verbal and written communication skills and interpersonal skills. * Proficient in Microsoft Office suite. * Excellent organization skills and project management. * Able to work equally well as part of a team or independently PROFILE * Bachelors Degree required in the Life Sciences, Regulatory Science/Affairs, Regulatory Compliance, or Drug Development preferred * Certification as a Quality Clinical Research Professional or GCP auditor is a plus * Experience of successful Pre-License Inspections and ability to conduct audits

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