Senior Manager, Quality Assurance

Location: Menlo Park, CA

Reporting to: Associate Director of Quality Assurance

Job summary

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

Requirements

Required knowledge

• 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.

Education

• Bachelor's degree in life sciences
• Advanced degree is a plus

Benefits

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