Associate Director, Quality Assurance, GCP - London
London, England, United Kingdom
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 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