Manager, Quality Assurance
Location: London, England
Reporting to: Director GMP QA
We are seeking an enthusiastic, highly motivated, and team-oriented individual for the newly established position of Manager QA, reporting to the Director GMP QA, within the Global GMP Quality team, to be based at the London office. In this role, the incumbent is responsible providing high quality support for manufacturing operations while ensuring compliance to protocols, GMP and safety regulations.
The incumbent will engage with Cell and Gene Therapy Technologies, Quality Control, Global Manufacturing and Supply Chain, CMC Lifecycle Management, Project Management, Regulatory, and other departments on a variety of activities. Such activities include investigations associated with product deviations/OOS/OOT, material specifications, stability testing and supporting regulatory authority inspections.
The incumbent will support Orchard’s clinical and commercial products and provide QA/QC expertise and project support to the Global GMP Quality team to develop and execute strategies to meet the team goals.
This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.
Key Elements and Responsibilities
· Review and approve master batch records, master labelling/packaging records, product specifications, PQR, sampling plan and other process related documents from contract manufacturing sites
· Perform batch record and data review/approval and manage process deviations for timely release
· Review and/or approve deviations, OOS, OOT, CAPAs, change control in an efficient manner for adequate and timely closeout of these events
· Write and periodically review SOPs where GMP QA is involved
· Review manufacturing and analytical validation protocols and reports
· Review and approve product stability reports; support the team managing stability programmes
· Review and approve CDMO methods and documentation in support of the development, qualification, validation and technology transfer of analytical methods for Orchard’s products.
· Authoring and/or reviewing regulatory documentation section where GMP QA input is needed
· Perform risk analysis as part of investigation and/or as needed per assigned project
· As appropriate, attend project meetings and provide input to quality-related issues
· Clearly communicate issues to vendors and Orchard’s management in a timely basis
· Support regulatory inspections; support internal and external audits on a need basis.
· Support activities at CDMOs ensuring compliance with cGMPs and Orchard’s best practices
· Drive quality oversight for assigned projects and activities and share quality culture with the project team
· Contributes to the goals for the QA function
· Seeks and analyses data from a variety of sources to support decisions
· Takes a creative approach to developing new and innovative ideas
· Sets clear and challenging goals within the assigned tasks while committing the QA team to improved performance; tenacious and accountable in driving results
· Comfortable with ambiguity and uncertainty; able to make decisions through complex situations
· Makes good decisions regarding complex QA related issues
· Demonstrates an aptitude for continuous improvement by being open to feedback and self-improvement
· Creates collaborative and trusting relationships internally and externally
· Celebrates and supports the success of the QA team