QA Analyst working on testing strategy for internal applications at Focus Group. Collaborating closely with development team to ensure product quality and stability.
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Onsite Senior Specialist, Quality Assurance, Compliance, Supplier Quality
Posted yesterday
About the role
- Senior QA Specialist providing quality oversight of suppliers for GMP manufacturing of gene therapies at OXB. Collaborating with suppliers and cross-functional teams for compliance and quality assurance.
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.
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
Job title
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