Senior Specialist, Quality Assurance

Join Us in Changing Lives At Location: Durham, NC, US Company: oxfordbiom 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 Quality Assurance Senior Specialist to join our Quality Assurance team. In this role, you will be accountable for quality oversight of raw material management including coordinating shipping and testing with contract testing labs, sampling, inspection, and release, playing a key part in advancing our mission and making a real difference. Your responsibilities in this role would be: Act as subject matter expert for raw material enrollment process at OXB Durham. Conduct raw material sampling and inspection. Collaborate with Manufacturing, MS&T and QA to complete phase appropriate Raw Material Risk Assessments. Collaborate with material suppliers to ensure proper supporting documentation is provided to OXB Durham. Quality oversight of method lifecycle and method implementation strategies Quality oversight of day-to-day QC operations Support regulatory inspections, internal audits, and client audits. Build and maintain cross-functional relationships with OXB colleagues and clients to collaborate, improve processes, and solve problems efficiently Independently escalation compliance concerns when observed QA support and ownership of QMS records including investigations, change controls, CAPAs, etc. Navigate compendia (USP and EP) to support material testing requirements and RM spec creation Final disposition of raw materials Support Supplier Change Notifications and facilitate impact assessment completion, with cross-functional teams, in QMS We are Looking For: Bachelor’s degree or higher in Life Sciences. Minimum 5 years of experience in the pharmaceutical or biopharmaceutical industry, including Quality Control, Quality Systems, or Quality Assurance, with at least 3+ years in Quality Control. Proven experience managing Change Controls, Deviations, and CAPAs. Strong knowledge of current Good Manufacturing Practices (cGMP). Demonstrated ability to drive a quality-focused culture, build effective processes, and collaborate across multiple sites and stakeholders in a fast-paced environment. 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? Nearest Major Market: Durham Nearest Secondary Market: Raleigh #J-18808-Ljbffr