Manager, Quality Control Operations

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
• Collaborate with internal/external, multidisciplinary teams and external partners to 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 intern/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 Statements of Work (SOW) and contracts for areas of responsibility
• Participate in budget, track KPI metrics and additional tasks as required.

Qualifications and Experience

• 5+ years experience in Quality Control in GMP setting. Experience in biologics required
• Bachelor's degree in analytical chemistry, microbiology or related life sciences field
• 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.)
• Ability to travel up to [5%]

Pay Range

$129,000 - $144,000 USD

Benefits

Not specified

Schedule

Based in our Lexington, MA office and requires employees to be onsite five days per week.