Manager, Quality Control Operations

Responsibilities

• Support Quality Control programs for commercial and late-stage clinical drug products
• Manage GMP reference standards including qualification, requalification, and inventory
• Coordinate shipping and sample management for routine testing activities
• Partner with contract testing labs to ensure on-time delivery of batch testing
• Drive completion of Quality System records including change control, deviations, and CAPAs
• Author, review, and approve QC protocols, reports, and laboratory data
• Generate Certificates of Analysis for product release
• Manage GMP reserve sample program and ensure availability of critical reagents
• Drive process improvements and ensure inspection readiness (ISO, GMP alignment)
• Manage SOW, contracts, budgets, and track KPI metrics

Requirements

• 5+ years of experience in Quality Control within a GMP setting
• Required experience in biologics
• BS in analytical chemistry, microbiology, or a related life sciences field
• Experience in routine GMP QC operations and reference standard management
• Knowledge of analytical methodologies for biologics and compendial testing
• Proven ability to manage projects and work with cross-functional teams and CMOs
• Proficiency with Microsoft Office suite
• Ability to travel up to 5%

About the Company

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications.