Quality Assurance Manager - San Francisco, Foster City, CA | Biospace
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Quality Assurance Manager

Orchard Therapeutics Limited

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Location:
San Francisco, Foster City, CA
Posted Date:
8/22/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Manager, QA, Quality, Quality Assurance,

Job Description


Location: Foster City, CA

Reporting to: Senior Vice President, Quality Assurance and Regulatory Affairs

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.

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.
•   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.

Requirements


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.

Job Requirements

•   Bachelor’s degree
•   Working knowledge of US and EU CGMPs
•   Extensive experience in the pharmaceutical/bio-pharm manufacturing industry with prior experience at the QA manager level
•   Experience working with Quality systems in support of both early and late stage development programs.