Sr QA Reviewer, Biologics Approval
Core
Provide quality assurance lifecycle support for analytical testing activities in biologics, focusing on oversight of method transfers, qualifications, validations, investigations, and risk assessments conducted by external partners.
Role type
Senior QA Reviewer (Biologics)
Builds
Supports GMP quality operations for biologics from cell bank through drug product.
Domain
Biologics / Pharmaceutical Manufacturing
Required skills
GMP compliance, analytical QA oversight, external lab documentation review, root cause analysis, quality risk management, FDA/ICH/GMP regulations knowledge
Preferred skills
Veeva Vault, document review workflows
Technologies
Veeva Vault
Responsibilities
Review and support approval of analytical methods, protocols, reports, and laboratory investigations; Assess root cause analyses and investigation conclusions; Partner with QC and Manufacturing teams to resolve quality issues; Apply Quality Risk Management principles to analytical activities; Assist with regulatory inspections and audits.
Seniority
Senior, hands-on IC