Senior Quality Specialist

Senior Specialist, Quality Assurance, Compliance and Supplier Quality 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 Senior QA Specialist, Compliance and Supplier Quality to join our team. In this role, you willbe responsible for providing quality oversight of suppliers and vendors supporting the manufacture, packaging, testing, and distribution of clinical and commercial gene and cell therapy products at OXB, playing a key part in advancing our mission and making a real difference. Your responsibilities in this role would be: Provide ongoing quality oversight of suppliers supporting GMP manufacturing, including raw materials, consumables, external laboratories, and transportation providers. Support supplier qualification, re-qualification, and lifecycle management activities using a risk-based approach. Support and/or conduct supplier audits (remote and on-site), including audit reporting, CAPA assessment, and follow-up. Maintain oversight of critical and single/sole-source suppliers, including identification of supply and quality risks and development of mitigation strategies. Manage supplier change notifications, ensuring appropriate internal documentation, quality risk assessment, and impact analysis in accordance with internal procedures. Confirm quality and technical agreements remain current and are not adversely impacted by proposed supplier changes. Provide Supplier Quality impact assessments for internally driven GMP changes and complete assigned change actions. Ensure supplier-reported deviations, OOS, and other quality events are logged, assessed, investigated, and closed in accordance with internal procedures. Collaborate with cross-functional SMEs to ensure timely investigation, root cause determination, and effective remediation. Critically review supplier investigations and CAPAs Support supplier and material quality risk assessments, including evaluation of data integrity, traceability, and supply continuity risks. We are Looking For: Bachelor’s degree or higher in Life Sciences, Chemistry, Engineering, or related field Minimum of 8 years of pharmaceutical industry experience, working in Supplier Quality role, and/or Quality/Compliance Experience in biotechnology industry preferred Strong knowledge of cGMP in the Pharma/Biotech industry to include FDA, EU, JP regulatory requirements as well as ICH/ISO guidelines Knowledge of aseptic and sterile product manufacturing processes and testing. Experience in Vendor Quality Oversight Thorough knowledge of and competence in core quality processes such as change control, deviations/OOS, CAPA, and complaints This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States. 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 30 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. Why Join Us? 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. #J-18808-Ljbffr