Oxford Biomedica

Senior Specialist, Quality Assurance, Compliance, Supplier Quality

Oxford Biomedica

full-time

Posted on:

Location Type: Office

Location: Durham • North Carolina • United States

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Job Level

Senior

About the role

  • 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.

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
  • 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
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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMP manufacturingsupplier qualificationsupplier auditsCAPA assessmentquality risk assessmentdata integrity evaluationchange controldeviationsOOScomplaints
Soft Skills
collaborationcommunicationcritical thinkingproblem-solvingattention to detail
Certifications
Bachelor’s degreeLife SciencesChemistryEngineering