Senior Specialist, Quality Assurance, Compliance and Supplier Quality
About The Position
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 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, playing a key part in advancing our mission and making a real difference.
Requirements
- 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
Nice To Haves
- Experience in biotechnology industry preferred
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.
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
- A company that lives its values: Responsible, Responsive, Resilient, Respect
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
