Associate Director, GMP QA Operations Lexington, MA

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. 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.

Kiniksa is seeking an experienced Associate Director, GMP Quality Assurance Operations to be a key leader within the Quality organization, responsible for providing hands‑on‑Quality Operations oversight for GMP manufacturing activities supporting clinical programs. This individual will oversee quality activities across the manufacture of master cell bank, working cell bank, drug substance and drug product/finished goods. The role is accountable for quality oversight of internal early‑phase manufacturing operations and external manufacturing at CDMO’s for late‑phase programs.

This role will partner with cross‑functional teams to ensure phase‑appropriate GMP compliance, effective execution of quality systems, and continuous inspection readiness in support of clinical development objectives.

This role is also responsible for supporting late‑stage technical transfer activities, including process transfer from development to commercial manufacturing, site‑to‑site transfers, and CMO/CDMO technology transfers. This role ensures that transfers are executed in compliance with global regulatory requirements, company quality standards, and product lifecycle expectations.

Reporting to the Senior Director, Quality. The role is based in our Lexington, MA office and requires employees to be onsite five days per week.

• Lead and execute GMP QA activities for development programs, including manufacture of master cell bank, working cell bank, drug substance and drug product/finished goods, in alignment with Kiniksa’s Quality System
• Support batch record review, disposition, and release activities for clinical materials, in accordance with established procedures; support QP/RP interactions and governance where applicable
• Provide hands‑on QA oversight of CDMO’s and key suppliers supporting development programs, including qualifications, audits, QTA, issue management and performance monitoring
• Serve as the primary QA point of contact for GMP activities related to tech transfer, scale‑up, process validation/qualification and analytical method validation and transfer
• Execute and support GMP quality Systems, including deviations, investigations, CAPA, change control, batch review, CPV, OOS/OOT management, and stability programs, ensuring timely and compliant closure
• Partner closely with CMC, Technical Operations, Analytical Sciences, Quality Control, and Supply Chain, and Regulatory teams to integrate quality oversight into program execution and manufacturing timelines
• Support review of CMC sections for IND’s, IMPD’s, BLA’s and MAA’s and support responses to health authority questions
• Contribute to quality risk management activities by identifying, assessing, and escalating GMP‑related risks, propose mitigation strategies in partnership with Quality Management
• Support labeling/packaging operations, temperature excursions, managing QP Declarations and Certification activities and QP release coordination activities, as applicable
• Track and report program‑level GMP quality metrics and trends; support continuous improvement initiatives across manufacturing operations
• Provide Quality oversight and approval for GMP technical transfer activities (clinical to commercial, site‑to‑site, CMO/CDMO) for both Drug Substance and Drug Product
• Ensure tech transfer strategies, protocols, reports, and control plans meet GMP, data integrity, and regulatory expectations
• Act as Quality…