Manager, Quality Control Operations

Role Summary

Reporting to the Associate Director, Quality Control Stability and Trending, the Manager, Quality Control Operations will be responsible for day-to-day oversight of routine batch testing at contract and internal Kiniksa testing laboratories. This individual will be responsible for sample management, data review, management of reference standards, critical reagents, certificate of analysis generation and delivery of QC results. This role will collaborate with internal/external, multidisciplinary teams and external partners. This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days (Monday - Thursday) in the office, and 1 day (Friday) remote.

Responsibilities

• Support Kiniksa’s Quality Control programs for commercial and late-stage clinical drug products, including combination products
• Responsible for GMP reference standards including leading the qualification, requalification and inventory management across all laboratories
• Participate on analytical teams to proactively support GMP routine operations
• Coordinate shipping and sample management for all routine testing activities
• Partner with contract testing labs to support routine release testing activities and ensure on time delivery of all batch testing including in-process, drug substance and drug product testing
• Drive the timely completion of Quality System records associated with sample testing to improve reliability of test methods, facilitate change, and evaluate and prevent exceptions (change control, deviations, and CAPAs)
• Author, review and approve related QC protocols, reports, and data
• Review and approve laboratory data and results, assuring their traceability and integrity
• Generate Certificates of Analysis for product release, and other certificates of GMP testing
• Coordinate testing of Kiniksa samples at internal/external testing laboratories
• Review, approve stability data, protocols, and reports as needed
• Assure availability of critical reagents and other essential materials
• Manage GMP reserve sample program
• Drive process improvements and ensure inspection readiness (ISO, GMP alignment) for area of responsibility
• Manage SOW and contracts for areas of responsibility
• Participate in budget, track KPI metrics and additional tasks as required

Qualifications

• 5+ years experience in Quality Control in GMP setting. Experience in biologics required
• Experience in routine GMP QC operations including reference standard management and review/release of QC testing data
• Knowledge of analytical methodologies common for biologics analysis in addition to compendial testing
• Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including CMOs
• Demonstrated strong written and verbal communication skills
• Proven mindset of proactive continuous improvement
• Efficient independent worker with ability to focus and drive for results
• Strong organizational skills and attention to detail
• Ability to work in a fast paced-environment and to handle multiple tasks
• Strong commitment to compliance and ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)

Education

• BS in analytical chemistry, microbiology or related life sciences field

Skills

• Microsoft Office suite proficiency

Additional Requirements

• Travel up to 5%