Director, Quality Assurance, GCP - Innovative Gene Therapy Start Up
Location: London, UK
Reporting to: Senior Vice President, Quality Assurance and Regulatory Affairs
Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created two years ago, it 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 VP QA and RA, located in Menlo Park, CA (US) and will be a key asset in the development of and management of the Quality System of the company and the compliance and filing for exciting ex-vivo Gene Therapy Products. This opportunity is unique due to the size of the team and the ground-breaking science.
- Manage the Good Clinical Practice (GCP) related day to day activities of the Quality Assurance department
- Be the reference QA GCP person for the company
- Be responsible for all GCP quality assurance activities, SOPs, policies and training
- Responsibilities include: preparing for, conducting, facilitating and responding to regulatory agency audits internally or at supplier sites/ preparing for and conducting internal audits / identifying needed actions as a result of internal or external audits, or internal process meetings
- Participate in establishing, maintaining and updating standards and ensuring compliance of standards with applicable regulatory requirements
- Review documentation to ensure that controlled documents are followed, standards of GCP quality are maintained, and documentation is complete
- Ensure procedural training is complete, documented and in compliance
- Oversee quality assurance planning for clinical study related activities
- Perform review of Corrective and Preventive Actions (CAPAs) and recommending effective solutions to enhance quality and efficiency, establishing GCP QA processes and standards and performing compliance related training
- Ensure systems at contract research organizations (CROs) are synchronized with current regulations, company's expectations and quality standards.
- Raise early signals to risk of business continuity due to any GCP quality issues. Provide direction on mitigation measures.
- Advanced degree preferred, e.g. MS or PhD in chemistry, cell biology, pharmacology, pharmacy or closely related field
- Extensive hands-on current experience in a GCP Quality organization within the pharmaceutical and/or biotechnology industries
- Direct experience in managing GCP Quality, and possess the ability to function effectively as a member of cross-functional project teams with demonstration of superior leadership skills and ability to work with remote team
- Extensive knowledge of global Good Clinical Practice, Regulatory Compliance and requirements for GCP Quality Systems
- Experience of successful Pre-Approval Inspections and ability to conduct audits
- Good understanding of the commercialization of Advanced Therapy Medicinal Products (ATMPs) in the EU and Regenerative Medicine Advanced Therapies (RMATs) in the US is a plus
- Certification as a Quality Clinical Research Professional or GCP auditor is a plus