Quality System Jobs in Raleigh, NC (NOW HIRING)

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.

Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us.

We're currently recruiting for a Senior Manager, Quality Assurance - Operations. This senior leadership role drives Quality Operations excellence across a multi-client GMP environment. You'll oversee manufacturing quality, batch disposition, and quality systems, while acting as a key interface between teams and clients to ensure compliant, inspection-ready operations. Supporting the growth of a new CGT CDMO facility, you'll partner cross-functionally to build scalable quality systems and enable operational readiness. playing a key part in advancing our mission and making a real difference.

Your responsibilities in this role would be:

• Lead and develop a high-performing Quality Operations team supporting GMP manufacturing, batch disposition, and quality systems within a multi-client CDMO environment.
• Provide strategic and operational oversight of QA activities across Manufacturing, Warehouse, QC, Supply Chain, and Facilities to ensure inspection readiness and compliance.
• Oversee QA floor support for GMP manufacturing operations, including batch record review, QA holds, and operational walkthroughs.
• Execute and support batch disposition decisions aligned with client agreements, regulatory requirements, and product specifications.
• Lead and approve quality system activities including deviations, investigations, CAPAs, change controls, and master batch records.
• Act as the primary Quality Operations interface for assigned clients, managing Q2Q interactions, communications, and audits.
• Support client audits and regulatory inspections, including preparation, hosting, and responses.
• Partner cross-functionally with Manufacturing, MSAT, QC, Engineering, and Supply Chain to support tech transfer, validation, and program delivery.
• Ensure effective quality oversight of facility operations, environmental monitoring, and contamination control programs.
• Drive continuous improvement initiatives to enhance right-first-time performance, reduce deviations, and improve operational efficiency.

We are Looking For:

• Bachelor's degree (or higher) in Life Sciences, Chemistry, Biology, Biochemistry, Engineering, or a related discipline.
• 8+ years of experience in GMP-regulated pharmaceutical or biotechnology environments.
• 4+ years of leadership experience managing QA or Quality Operations teams.
• Strong expertise in Quality Assurance supporting GMP manufacturing, including batch review and disposition.
• Experience in cell and gene therapy, viral vectors, or advanced biologics manufacturing environments.
• Proven experience in CDMO or multi-client environments with client-facing quality responsibilities.
• Strong knowledge of GMP processes, aseptic manufacturing, environmental monitoring, and contamination control.
• Demonstrated ability to build and lead high-performing teams and foster a strong quality culture.
• Excellent communication, stakeholder management, and problem-solving skills, with a risk-based decision-making approach.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

About Us:

OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy 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, OXB has 30 years of experience in viral vectors; the driving force behind the majority of cell and 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), adenovirus and other viral vector types. OXB's world-class capabilities range from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.

OXB offers a vast number of technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (the TetraVecta system), a dual-plasmid system for AAV production, suspension and perfusion process using process enhancers and stable producer and packaging cell lines.

OXB, a FTSE250 and FTSE4Good constituent, is headquartered in Oxford, UK. It has development and manufacturing facilities across Oxfordshire, UK, Lyon and Strasbourg, France, Bedford MA, and Durham NC, US.

Why Join Us?

Competitive total reward packages
Wellbeing programs 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?