Quality Assurance Manager
The Orchard Therapeutics team based in Foster City 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 directly to the Senior Director of Quality Assurance and will be a key asset in the set-up of the Quality Department. This opportunity is unique due to the size of the team and exposure that the successful candidate will have to senior management and key decision makers.
- Review and approve master batch records, master labeling/packaging records, product specifications and other process related documents from contract sites.
- Perform batch release through batch record and data review/approval and managing process deviations for timely release.
- Review and/or approve deviations, OOSs, CAPAs, change control in an efficient manner for adequate and timely closeout of these events.
- Maintain the vendor qualification program through timely audits and follow-up actions.
- Schedule, perform and manage internal GMP audits.
- Write, revise and periodically review SOPs to further develop the Quality System and control over the quality of vendor services and products.
- Review and approve manufacturing validation protocols and reports.
- Manages product recalls and complaint investigations.
- Assist in the development and tracking of Quality metrics. Prepare metrics for the Management Review and Annual Product Review.
- Review and approve of product stability reports.
- Assist in the QC review of various documents, including regulatory dossiers and reports.
- As appropriate, attend project meetings and provide development quality input and lead the resolution of quality-related issues.
- Clearly communicate issues to vendors and Orchard Therapeutics management in a timely basis.
- Supports the preparation, coordination, and management of regulatory agency Preapproval or regular inspections.
- Support regulatory inspections; internal and external
- Provides Quality Assurance leadership, guidance, and direction to CMOs consistent with CGMPs and Orchard Therapeutics quality compliance best practices.
- Strong technical/analytical skills to identify and solve problems.
- Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
- Proven ability to work with a high level of integrity, accuracy, and attention to detail.
- Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
- Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
- Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strength decision-making.
- Proactively seeks out and recommends process improvements.
- Resourceful, creative, enthusiastic, and results-oriented.
- Entrepreneurial, enjoys working in a fast-paced, small-company environment.
- Bachelor’s degree
- Working knowledge of US and EU CGMPs
- Minimum 10 years’ experience in the pharmaceutical/bio-pharm manufacturing industry with at least 5 of those years at the QA manager level
All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.