Senior Specialist, Quality Assurance, Compliance, Supplier Quality

Role Overview

• 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
• A company that lives its values: Responsible, Responsive, Resilient, Respect