QA Manager: Quality Management Systems & Vendor Oversight.
Manager, Quality Management Systems & Vendor Oversight, Corporate QA
Location: London, UK
Reporting to: Director Corporate Quality Assurance
Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created three years ago, it is in an exciting 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 Director Corporate Quality, located in Boston, MA (US) and will be responsible for the management of the Orchard Quality Management System (QMS) to ensure compliance with applicable US and EU Good x Practice (GxP) standards and requirements. This role will also be responsible for vendor oversight activities including risk assessments ensuring vendors utilized by the company are appropriately qualified.
Management and oversight of the Orchard Quality Management Systems. Manage and oversees day-to-day maintenance of Orchard Quality System elements, including but not necessarily limited to Deviation, CAPA, OOS, Complaint, and Change Control External vendor due diligence activities including qualification audits Participate in, support and represent the Quality Management System in internal management reviews as well as in regulatory and third-party inspections at Orchard Lead Vendor Management Quality function Support Risk Assessments for Orchard vendors to ensure appropriate qualification activities are conducted. Write, revise and periodically review SOPs to further develop the Quality System and control over the quality of vendor services and products. Assist in the development and tracking of Quality metrics (KPI). Prepare metrics for the Management Review and Annual Product Review. As appropriate, attend project meetings and lead the resolution of quality-related issu...