Assoc. Director, Quality - Commercial

About Kiniksa Pharmaceuticals

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapies for diseases with unmet needs, with a specific focus on cardiovascular indications. Grounded in rigorous science and bold innovation, the company leverages deep expertise in immunology and inflammation to advance a growing portfolio of approved and investigational medicines. Our lead product, ARCALYST®, stands as the first and only FDA-approved therapy for recurrent pericarditis.

At Kiniksa, we foster a highly collaborative, patient-first culture led by accomplished life sciences leaders. 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.

About the Role

The Associate Director, Quality serves as the Subject Matter Expert (SME) for technical transfer activities, providing essential leadership and oversight to ensure the successful transition of products from development to commercial manufacturing. This role is pivotal in executing process transfers from development to commercial sites, site-to-site transfers, and CMO/CDMO technology transfers.

In this position, you will partner closely with Technical Operations, MS&T, Manufacturing, Supply Chain, Regulatory Affairs, and external partners to ensure all transfers are executed in strict compliance with global regulatory requirements, company quality standards, and product lifecycle expectations. You will act as the primary Quality lead on the Tech Transfer Team, driving the definition and execution of comparability, validation, and verification strategies. Your work will directly influence the readiness for Process Performance Qualification (PPQ), conformance, and commercial launch, ensuring that all GMP documentation, risk assessments, and regulatory filings meet the highest standards of integrity and compliance.

Equal Opportunity & Culture

Kiniksa is an Equal Opportunity employer and will consider applicants without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, disability status, or any other legally protected category. We are committed to ensuring that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.