Senior Manager, Quality Assurance - P19-13
Menlo Park, California, United States
Location: Menlo Park, CA
Reporting to: Associate Director of Quality Assurance
The Orchard Therapeutics team based in Menlo Park 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 Director of Quality Assurance and will be a key asset in continuing the set-up of the Quality Department.
Key Elements and Responsibilities
- 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.
- 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.
- 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
- Extensive knowledge of US GMP, EU experience is a plus
- Prior experience working in an operational role with CDMOs
- Demonstrated experience performing batch release
- Experience with batch record review
- Extensive experience in the pharmaceutical/bio-pharm manufacturing industry with prior experience at the QA Manager level
- Experience building a team
- Experience working with Quality systems in support of both early and late stage development programs.
Skills & Abilities
- 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 in life sciences
- Advanced degree is a plus
Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify