Sr QA Reviewer, Biologics Approval

Senior QA Reviewer providing quality assurance oversight for analytical testing activities in biologics drug development. The role focuses on reviewing method transfers, validations, investigations, and risk assessments conducted by external partners, with emphasis on GMP compliance and regulatory standards.

Responsibilities

• Provide QA oversight for analytical testing across biologics product lifecycle from cell bank through drug product
• Review and approve analytical methods, protocols, reports, and laboratory investigations including deviations and out-of-specification events
• Assess analytical risks and support product quality decisions in partnership with cross-functional teams
• Review root cause analyses, investigation conclusions, and develop remediation strategies
• Maintain knowledge of FDA, Health Canada, ICH, and global GMP requirements for biologics analytical testing

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Biology, Immunology, or related lab science
• Minimum 4+ years of relevant QA experience in analytical quality assurance
• Experience providing QA oversight for GMP QC operations
• Biologics industry experience including Drug Substance, Drug Product, or Cell Bank activities
• Experience reviewing documentation from external contract laboratories
• Strong GMP compliance knowledge and ability to critically review technical documentation
• Independent judgment to challenge scientific rationale and identify quality concerns