Senior Manager, Quality Assurance (EU Vector) - QA2


London, England, United Kingdom

Quality Assurance

The Orchard Therapeutics team based in London 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 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

Required knowledge

  • Working knowledge of EU CGMPs; knowledge of US cGMP is an advantage
  • 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.

Requirements

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 is preferred