Senior Quality Assurance Specialist

3 weeks ago


London, Greater London, United Kingdom Orchard Therapeutics Full time

About the Role

We are seeking an experienced Quality Assurance Specialist to join our Global GMP Quality team at Orchard Therapeutics, an international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Responsibilities

The successful candidate will be responsible for providing high-quality support for manufacturing operations, ensuring compliance to protocols, GMP, and safety regulations. This includes:

  • Performing batch record and data review/approval and managing process deviations for timely release
  • Reviewing and/or approving deviations, OOS, OOT, CAPAs, change control in an efficient manner for adequate and timely closeout of these events
  • Supporting the GMP QA team to maintain governance and oversight of change controls
  • Supporting the GMP QA team for issuing and reviewing vendors qualification documents including quality agreements, vendor lists, and audit plans
  • Reviewing and approving product stability reports; supporting the team in managing stability programs
  • Writing, revising, and periodically reviewing SOPs
  • Performing risk analysis as part of investigation and/or as needed per assigned project
  • Attending project meetings and providing input to quality-related issues
  • Clearly communicating issues to vendors and Orchard's management in a timely basis
  • Supporting regulatory inspections; supporting internal and external audits on a need basis
  • Supporting activities at CDMOs ensuring compliance with cGMPs and Orchard's best practices

Requirements

The ideal candidate will have:

  • Experience in the biotechnology or pharma industry within the quality department
  • Experience with ATMP (Advanced Therapy Medicinal Products) and/or Biosimilars, sterile, and/or aseptic manufacturing desirable
  • Experience of handling deviations, change controls, OOS/OOT, and related CAPAs
  • Skilled in writing and reviewing SOPs and work instructions
  • Sound understanding and demonstrated application of root cause analysis tools
  • In-depth working knowledge of cGMPs, ICH guidelines, and applicable EU/US regulatory requirements for biological products

Education

A BSc or higher degree in biology, biochemistry, or other relevant scientific discipline is required.

About Orchard Therapeutics

Orchard Therapeutics is an international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.



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