Senior Manager, Quality Assurance

Orchard Therapeutics Menlo Park , CA 94025

Posted 2 weeks ago

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

  • Bachelors 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

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VIEW JOBS 7/3/2019 12:00:00 AM 2019-10-01T00:00 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 Orchard Therapeutics Plc Menlo Park CA

Senior Manager, Quality Assurance

Orchard Therapeutics