Principal QA Specialist - Sterility Assurance

Responsibilities

• Defining, implementing, and overseeing OXB's sterility assurance strategy, including facility design, qualification, airflow/HEPA certification, media fills, environmental monitoring, container closure integrity, and cleaning/disinfection.
• Promoting compliance with sterility assurance regulations and best practices across the business.
• Supporting aseptic manufacturing and environmental monitoring for VS and VP operations, including contamination control documentation and aseptic fill guidance.
• Leading or supporting sterility assurance investigations, risk assessments, and validation activities.
• Driving continuous improvement in sterility assurance practices, processes, and systems, including adopting new regulations and technologies.
• Managing sterility assurance audits, inspections, and supplier quality oversight, including aseptic processing CMOs.

• Extensive knowledge of GMP, sterile product manufacture, and pharmaceutical regulations/standards.
• BSc degree in Microbiology or related field (advanced degree preferred).
• Proven skills in influencing people using negotiation and interpersonal skills to drive through project priority tasks to ensure on‑time delivery of milestones.
• Proven experience in aseptic manufacturing environments (clean rooms, isolators, sterility test isolators).
• Strong technical expertise in sterility assurance, contamination control, and cleanroom standards, with hands‑on implementation experience.
• Experience in sterility assurance validation, product validation, and supplier quality management.
• Ability to interpret worldwide aseptic/sterility regulations into practical, compliant execution.
• Experience interacting with regulatory authorities during inspections.

• At OXB, our people are at the heart of everything we do. We're on a mission to enable life‑changing therapies to reach patients around the world—and we're looking for passionate individuals who embody our core values every day:
  Responsible, Responsive, Resilient, and Respectful.
• OXB is a quality and innovation‑led viral vector CDMO with a mission to enable its clients to deliver life‑changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 30 years of experience in viral vectors; the driving force behind the majority of gene therapies.
• OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno‑associated virus (AAV) and adenoviral vectors. OXB's world‑class capabilities span from early‑stage development to commercialisation. These capabilities are supported by robust quality‑assurance systems, analytical methods, and depth of regulatory expertise.

• Competitive total reward packages.
• Wellbeing programmes that support your mental and physical health.
• Career development opportunities to help you grow and thrive.
• Supportive, inclusive, and collaborative culture.
• State‑of‑the‑art labs and manufacturing facilities.
• A company that lives its values:
  Responsible, Responsive, Resilient, Respect.

• Collaborate. Contribute. Change lives.