Senior Specialist, Quality Assurance, Compliance and Supplier Quality

oxfordbiom•Durham, NC

30d•Onsite

About The Position

OXB is seeking a Senior QA Specialist, Compliance and Supplier Quality to provide quality oversight of suppliers and vendors supporting the manufacture, packaging, testing, and distribution of clinical and commercial gene and cell therapy products. This role is crucial in advancing OXB's mission to enable life-changing therapies to reach patients worldwide.

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
External applicants must be eligible to work in the United States.

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.