Associate Director GMP QA Operations — Lexington, MA at

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

We are seeking an experienced Associate Director, GMP Quality Assurance Operations to serve as a key leader within our Quality organization. This role is designed to provide hands-on oversight for GMP manufacturing activities supporting our clinical programs. You will be accountable for quality activities across the manufacture of master cell banks, working cell banks, drug substance, and drug product/finished goods.

In this position, you will oversee quality for internal early-phase manufacturing operations as well as external manufacturing at CDMOs for late-phase programs. You will partner closely with cross-functional teams to ensure phase-appropriate GMP compliance, the effective execution of quality systems, and continuous inspection readiness in support of our clinical development objectives. Additionally, you will play a pivotal role in supporting late-stage technical transfer activities, ensuring seamless process transfers from development to commercial manufacturing while adhering to global regulatory requirements and company quality standards.

Our Culture and Values

Kiniksa is committed to a culture where employees are empowered to drive innovation. We value a patient-first approach and believe in the power of collaboration to solve complex challenges. As part of our team, you will embody our cultural values and align your actions with our departmental goals and company mission to improve patient lives.

Equal Opportunity Employer

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.

Application Instructions

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.

Work location

Work model: On-site

4, Hathaway Road, Lexington, Middlesex County, Massachusetts, 02420, United States

Lexington, Massachusetts

Key Responsibilities

check_circleLead and execute GMP QA activities for development programs including master cell bank and drug product manufacturing
check_circleSupport batch record review, disposition, and release activities for clinical materials in alignment with quality systems
check_circlePartner with cross-functional teams to integrate quality oversight into program execution and manufacturing timelines
check_circleSupport review of CMC sections for regulatory filings and responses to health authority questions
check_circleEnsure tech transfer strategies, protocols, and control plans meet GMP, data integrity, and regulatory expectations
check_circleConfirm readiness for PPQ, conformance, and commercial launch from a Quality standpoint
check_circleApprove tech transfer related GMP documentation including protocols, validation documents, and risk assessments
check_circleHost regulatory inspections and partner audits related to transferred products and manufacturing operations

Requirements

verifiedBachelors in scientific discipline or related discipline
verifiedAdvanced degree preferred
verifiedMinimum 8 years of progressive experience in GMP QA within biotech or pharmaceutical development
verifiedHands-on experience supporting biologics manufacturing
verifiedExperience supporting GMP technical transfer activities
verifiedStrong working knowledge of global GMP regulations (FDA, EMA, ICH)
verifiedProficient with Microsoft Office suite
verifiedAbility to travel up to 15%

Nice to Have

Advanced degree in a scientific discipline or related field.

Skills, education and keywords

Skills: GMP, Quality Assurance, Master Cell Bank, Working Cell Bank, Drug Substance, Drug Product, Cdmo, Cmo, Batch Record Review, QP.

Education: Bachelor's in scientific discipline required; Advanced degree preferred.

Frequently asked questions about Associate Director, GMP QA Operations at Kiniksa Pharmaceuticals

What does a Associate Director, GMP QA Operations at Kiniksa Pharmaceuticals do?expand_more

A Associate Director, GMP QA Operations at Kiniksa Pharmaceuticals is responsible for the following: Lead and execute GMP QA activities for development programs including master cell bank and drug product manufacturing; Support batch record review, disposition, and release activities for clinical materials in alignment with quality systems; Partner with cross-functional teams to integrate quality oversight into program execution and manufacturing timelines; and Support review of CMC sections for regulatory filings and responses to health authority questions.

What are the requirements for this Associate Director, GMP QA Operations role?expand_more

To qualify for the Associate Director, GMP QA Operations at Kiniksa Pharmaceuticals position, applicants should have: Bachelors in scientific discipline or related discipline; Advanced degree preferred; Minimum 8 years of progressive experience in GMP QA within biotech or pharmaceutical development; Hands-on experience supporting biologics manufacturing; Experience supporting GMP technical transfer activities; and Strong working knowledge of global GMP regulations (FDA, EMA, ICH).

Where is the Associate Director, GMP QA Operations role at Kiniksa Pharmaceuticals located?expand_more

Associate Director, GMP QA Operations at Kiniksa Pharmaceuticals is based in 4, Hathaway Road, Lexington, Middlesex County, Massachusetts, 02420, United States. This is a on-site role.

Is this Associate Director, GMP QA Operations job remote, hybrid, or on-site?expand_more

Kiniksa Pharmaceuticals has listed this Associate Director, GMP QA Operations role as on-site.

How much experience is required for this Associate Director, GMP QA Operations role?expand_more

Associate Director, GMP QA Operations at Kiniksa Pharmaceuticals typically requires 8+ years of relevant experience at the lead level.

What skills do you need for the Associate Director, GMP QA Operations role at Kiniksa Pharmaceuticals?expand_more

Key skills for Associate Director, GMP QA Operations at Kiniksa Pharmaceuticals include GMP; Quality Assurance; Master Cell Bank; Working Cell Bank; Drug Substance; Drug Product; Cdmo; and Cmo.

What education is required for Associate Director, GMP QA Operations at Kiniksa Pharmaceuticals?expand_more

Educational requirements for this role: Bachelor's in scientific discipline required; and Advanced degree preferred.

What category does the Associate Director, GMP QA Operations role belong to?expand_more

Associate Director, GMP QA Operations at Kiniksa Pharmaceuticals is part of the scientific & qa job category on Recrutus.

Associate Director, GMP QA Operations