Location:London, England (Hybrid Working)

Reporting to:Director GMP QA

Job summary

We are seeking an enthusiastic, highly motivated, and team-oriented individual for the newly established position of Specialist QA, reporting to the Director GMP QA, within the Global GMP Quality team, to be based at the London office. In this role, the incumbent is responsible for providing high quality support for manufacturing operations while ensuring compliance to protocols, GMP and safety regulations.

The incumbent will engage with Cell and Gene Therapy Technologies, Quality Control, Global Manufacturing and Supply Chain, CMC Lifecycle Management, Project Management, Regulatory, and other departments on a variety of activities. Such activities include investigations associated with product deviations/OOS/OOT, change controls, stability testing and supporting regulatory authority inspections.

The incumbent will support Orchard’s clinical and commercial products and provide QA/QC support as well as project support to the Global GMP Quality team to develop and execute strategies to meet the team goals.

This an exciting opportunity for a well-qualified candidate to join an international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Key Elements and Responsibilities

· Perform batch record and data review/approval and manage process deviations for timely release

· Review and/or approve deviations, OOS, OOT, CAPAs, change control in an efficient manner for adequate and timely closeout of these events

· Support the GMP QA team to maintain governance and oversight of change controls

· Support the GMP QA team for issuing and reviewing vendors qualification documents including quality agreements, vendor lists and audit plans

· Review and approve product stability reports; support the team in managing stability programmes

· Write, revise, and periodically review SOPs

· Perform risk analysis as part of investigation and/or as needed per assigned project

· As appropriate, attend project meetings and provide input to quality-related issues

· Clearly communicate issues to vendors and Orchard’s management in a timely basis

· Support regulatory inspections; support internal and external audits on a need basis

· Support activities at CDMOs ensuring compliance with cGMPs and Orchard’s best practices.

Requirements

Required Knowledge

· 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.

Skills & Abilities

· Creative problem solver, with clearly demonstrated problem-solving skills.

· Well-organized and detail oriented with good verbal and written communication skills.

· Ability to operate in a fast-paced, multi-disciplinary industrial environment

· Support quality oversight for assigned activities and share quality culture across Orchard.

· Seek and analyse data from a variety of sources to support decision making.

· Proactive approach and hands-on when it comes to managing activities under responsibility.

· Makes good decisions regarding complex QA related issues.

· Demonstrates an aptitude for continuous improvement by being open to feedback and self-improvement.

· Creates collaborative and trusting relationships internally and externally.

· Celebrates and supports the success of the QA team.

Education

· BSc or higher degree in biology, biochemistry or other relevant scientific discipline.