Principal QA Specialist - Sterility Assurance

Oxford BioMedica Limited; Oxford; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading biotechnology company in Oxford seeks a specialist to oversee sterility assurance strategies, support aseptic manufacturing, and ensure regulatory compliance. The ideal candidate will hold a BSc in Microbiology or a related field, with significant experience in sterility assurance and aseptic environments. The role offers a competitive reward package and development opportunities in a collaborative culture.

Benefits

Competitive total reward packages

Wellbeing programmes

Career development opportunities

Supportive and inclusive culture

State-of-the-art labs and facilities

Qualifications

• Proven experience in aseptic manufacturing environments, including cleanrooms.
• Hands-on implementation experience in sterility assurance.
• Experience interacting with regulatory authorities during inspections.

Responsibilities

• Promote compliance with sterility assurance regulations.
• Support aseptic manufacturing and environmental monitoring.
• Lead sterility assurance investigations and validation activities.
• Drive continuous improvement in sterility assurance practices.
• Manage sterility assurance audits and inspections.

Skills

Negotiation abilities

Interpersonal skills

Technical expertise in sterility assurance

Experience in aseptic manufacturing

Ability to interpret regulations

Education

BSc degree in Microbiology or related field

Tools

Cleanroom standards

Job description

Overview

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. OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, AAV, and adenoviral vectors. 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.

Responsibilities

• 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.

Qualifications

• 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 (cleanrooms, 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.

Benefits

• 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. Ready to Make a Difference? Collaborate. Contribute. Change lives.