Director, Quality Assurance - Innovative Gene Therapy
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 US related day to day activities of the Quality Assurance department
- Be responsible for all quality assurance activities, e.g. GxP (Good laboratory, clinical, manufacturing, distribution and documentation practices), company SOPs and policies, QA validation activities and compliance 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 quality are maintained, and documentation is complete
- Ensure procedural training is complete, documented and in compliance
- Oversee quality assurance planning for study related activities
- Perform review of quality metrics, CAPA findings and business process improvement opportunities, and recommending effective solutions to enhance quality and efficiency, establishing QA processes and standards and compliance related training
- Ensure systems at US partners (sites, CMOs and affiliates) are synchronized with current regulations, company's expectations and quality standards.
- Be accountable for quality products and processes under the scope of the business.
- Raise early signals to risk of business continuity due to any quality issues. Provide direction on mitigation measures.
- Provide leadership and support to Quality Managers worldwide
- Other activities as may be assigned
- 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 Quality organization within the pharmaceutical and/or biotechnology industries
- Direct experience in managing 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 members
- Extensive knowledge of QA, CQA, QC, Regulatory Compliance and US requirements for Quality Systems (knowing US requirements as well is a plus)
- Experience with successful regulatory agency and Pre-Approval Inspections
- Ability to conduct audits
- A thorough knowledge and understanding of Canadian, US FDA and European regulations (GMP), as well as experience with GLPs.
- 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
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.