Senior Quality Systems Officer

OXB; Oxford; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading biopharmaceutical firm in Oxford is seeking a Senior Quality Systems Officer to manage Quality Management Systems (QMS) and oversee documentation related to computer systems validation. Candidates should possess A-Level education in science or equivalent, along with significant experience in the biopharmaceutical industry. The role involves driving projects for quality improvements, managing supplier qualifications, and ensuring regulatory compliance for ongoing operations. The company values collaboration, inclusivity, and offers numerous wellbeing programmes.

Benefits

Wellbeing programmes

Career development opportunities

Supportive and inclusive culture

State-of-the-art labs and manufacturing facilities

Qualifications

• Significant experience in Quality Management Systems within the biopharmaceutical/pharmaceutical industry.
• 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.

Responsibilities

• Maintain Quality Management Systems (QMS) including CSV documentation.
• Lead improvements to the QMS, driving projects and compliance monitoring.
• Manage supplier qualification and maintenance.

Skills

Quality Management Systems

GMP and regulatory standards

Data integrity

Continuous improvements

Microsoft Office (Word, Excel, Outlook, PowerPoint)

Education

A-Level education in science or equivalent

Job description

AtOXB, 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.

Senior Quality Systems Officer

In this role, you will be responsible for maintaining the Quality Management Systems (QMS), inclusive of review of Computerised System Validation (CSV).

Your responsibilities

• The reviewing of Computer Systems (CSV) lifecycle documentation.
• 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 Supplier Complaints.
• 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.

We are looking for

• A‑Level education in (science preferred) or equivalent experience.
• Significant experience in Quality Management Systems within the biopharmaceutical/pharmaceutical industry,
• 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, the reviewing of CSV (CSV), and software development lifecycle concepts.
• Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Ability to identify, prioritise, and drive continuous improvements in quality systems.

About us

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 commercialization. These capabilities are supported by robust quality‑assurance systems, analytical methods, and depth of regulatory expertise.

Benefits we offer

• 🧘 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.