Senior Quality Systems Officer

Job description

Join Us in Changing Lives

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
.

We’re currently recruiting for a Senior Quality Systems Officer to join our QA team. In this role, you will be responsible for maintaining the Quality Management Systems (QMS) and Compliance (including CSV – Computerised System validation) at Oxford Biomedica and will promote ongoing continuous improvement to meet business needs.

• Leading improvements to the Quality Management System (QMS), driving projects, updates, and compliance monitoring.
• Managing supplier qualification and maintenance.
• Reviewing and approving Quality records, including Deviations, CAPAs, Change Controls, and CSV lifecycle documents.
• Managing the change control process to assess impact and ensure regulatory compliance.
• Providing Quality support for new products, projects, suppliers, and service providers, including qualification and complaint management.
• Coordinating and supporting internal, supplier, client, and regulatory audits, including follow-up actions and CAPA tracking.
• Contributing to wider Quality initiatives such as Annual Product Quality Reviews, Management Review Forums, and regulatory gap analyses.
• Delivering training on Quality Systems and ensuring data integrity across both paper-based and electronic systems.

• Significant experience in Quality Systems within the biopharmaceutical/pharmaceutical industry, with a strong understanding of GMP and regulatory standards.
• Proven background in Pharmaceutical QA, including audits, inspections, investigations, root cause analysis, and change control.
• Experience managing electronic Quality Management Systems and document/records management in a regulated environment.
• In-depth knowledge of data integrity, computer systems validation (CSV), and software development lifecycle concepts.
• Strong IT skills, including advanced use of Microsoft Office (Word, Excel, and related tools).
• Ability to identify, prioritise, and drive continuous improvements in quality systems.
• Ability to identify, prioritize, and implement actions to continuously improve quality systems.

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 25 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

We want you to feel inspired every day. At OXB, we’re future-focused and growing fast. We succeed together—through passion, commitment, and teamwork.

Collaborate. Contribute. Change lives.