OXB · 9 hours ago
Senior Specialist, Quality Assurance, Compliance and Supplier Quality
Durham, NC
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expOXB 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. In this role, you will be 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.
BiotechnologyGeneticsTherapeutics
No H1B
Responsibilities
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
Qualification
Required
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
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
Preferred
Experience in biotechnology industry preferred
Benefits
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
Company
OXB
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.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$217.05MKey Investors
Oaktree Capital ManagementSerum Institute of India Pvt. Ltd.
2025-08-01Post Ipo Debt· $60M
2021-09-22Post Ipo Equity· $68.08M
2019-05-01Post Ipo Equity· $69.83M
Leadership Team
Emily Yu
Oxford BioMedica CMO
Recent News
2026-01-16
2026-01-16
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