Kiniksapharmaceuticals

Manager, Quality Control Operations

Lexington, MA

Sponsorship not specified$129k-$144kDetected 48 days ago

ExcelInventory ManagementGMPFDA RegulatoryCommunicationOrganizational SkillsMicrosoft OfficeSharePoint

About the role

Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders.
At Kiniksa, talented individuals are trusted and empowered to make a real impact-shaping the future of medicine while improving the lives of patients who need it most.
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.

Support Kiniksa's Quality Control programs for commercial and late-stage clinical drug products, including combination products
Participate on analytical teams to proactively support GMP routine operations
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)
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
Proven ability to manage end-to-end laboratory operations, including reference standards, critical reagents, stability programs, and coordination with internal labs and external CMOs
Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including CMOs
Efficient independent worker with ability to focus and drive for results

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 mindset of proactive continuous improvement
Ability to work in a fast paced-environment and to handle multiple tasks
Ability to travel up to [5%]
Participate in budget, track KPI metrics and additional tasks as required.

$129,000 - $144,000 USD
Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.

decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

This listing is sourced directly from Kiniksapharmaceuticals's careers page and normalized into a canonical job model.