--- title: 'Specialist / Senior Specialist - Quality Assurance at Kiniksa Pharmaceuticals' canonical: 'https://feeny.ai/job/specialist-senior-specialist-quality-assurance-kiniksa-pharmaceuticals-lexington-c3jz7tpapkn1' type: 'job' last_seen: '2026-09-14' --- # Specialist / Senior Specialist - Quality Assurance at Kiniksa Pharmaceuticals - **Company:** Kiniksa Pharmaceuticals - **Location:** Lexington, MA - **Compensation:** $108k–$118k - **Posted:** 2026-08-04 - **Last confirmed live:** 2026-09-14 - **Apply:** https://job-boards.greenhouse.io/kiniksapharmaceuticals/jobs/4354278009 ## Job description 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. The Specialist/Sr. Specialist, QA is recognized as a subject matter expert in the application of quality assurance and compliance. The incumbent will provide QA support for internal/external manufacturing and laboratory operations, quality control, analytical development in support of batch disposition activities. The incumbent will perform review of drug substance/drug product/finished drug product manufacturing records and associated documents (e.g. Deviations, change controls, investigations, supplier change notifications) for products that will be released for use in Kiniksa programs. This role is based in our Lexington, MA office and requires employees to be onsite five days per week. Responsibilities (including, but not limited to): - Oversee quality operations at Kiniksa and at external service providers (CDMO’s/CTL’s) - Review and approve service provider’s GMP documentation - Review and approve master/executed batch records, packaging records for, drug substances, drug product/finished drug product - Perform GMP raw material release activities for Kiniksa internal manufacturing operations - Review and approve laboratory data related to release and stability of GMP materials, qualification of test methods and reference standards, including protocols, data and reports - Collaborate with external service providers and internally with QA, RA, CMC teams to support the timely review and approval of documents - Review records including audit trails and ensure integrity of data and results generated by Kiniksa and external CDMO’s/CTL’s - Support batch disposition activities, including data upload, review, and documentation in applicable quality systems - Compile data for Quality system reviews - Evaluate and support GMP activities for continuous improvement - Other Quality Assurance responsibilities as assigned Standout Skills for Impact: - QA experience in a GMP-regulated environment - Experience with Veeva QualityDocs and Veeva QMS - Excellent verbal and written communication skills with proven track record of communication with internal and external service providers - Knowledge of industry standards, current GMP (21CFR Parts 210 & 211 & Part 11 and EudraLex) and other agency standards Qualifications and Experience: - Bachelors in a scientific discipline with 4+ years of experience in the FDA regulated pharmaceutical/biotech industry with GMP manufacturing operations analytical development and quality - Experience in Biologics and Combination Products (Cell and Gene Therapy, monoclonal antibodies) is preferred - Experience with review of GMP manufacturing records (Master/Executed batch records, change controls, deviations, investigations, change controls, product complaints) associated with clinical programs - Hands-on experience with laboratory testing and method validation - Familiarity with a wide range of test methods needed for evaluation of diverse samples, such as cell banks, drug substance, drug product, and combination products is a plus - Strong team player that has a customer service approach and is solution oriented - Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external service providers in a professional and collaborative manner Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks. Pay Range $107,500—$117,500 USD Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure 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. ## About Kiniksa Pharmaceuticals ## Company Overview - **One-liner**: Kiniksa Pharmaceuticals is a global biopharmaceutical company focused on discovering, developing, and commercializing novel, transformative therapies for patients with significant unmet medical needs, with a primary focus on cardiovascular diseases and immune modulation. - **Entity Type**: Public (NASDAQ: KNSA) - **Headquarters**: Lexington, Massachusetts, USA (with additional offices in La Jolla, CA; Zug, Switzerland; and London, UK) - **Founded**: 2015 - **Founders**: Sanj K. Patel (CEO & Chairman) ## Core Business - **Primary industry/industries**: Biopharmaceuticals, Biotechnology - **Target customers**: Patients, healthcare providers, and payers (B2B/B2C model in specialty pharma) - **Mission or purpose statement**: Dedicated to placing patients first and driving innovation in novel, life-changing therapies to address unmet medical need. The company operates under the belief that "every second makes a difference for patients living with debilitating diseases." ## Products & Services - **ARCALYST® (rilonacept)**: An FDA-approved treatment for recurrent pericarditis — the first and only FDA-approved therapy for this indication. It is an interleukin-1 alpha and beta cytokine trap. - **Mavrilimumab**: A clinical-stage anti-GM-CSF receptor alpha monoclonal antibody. A Phase 2 trial in non-mechanically ventilated severe COVID-19 patients yielded positive results. Kiniksa and Huadong Medicine have a collaboration to develop and commercialize it in the Asia Pacific region (excluding Japan). - **Vixarelimab**: A clinical-stage asset acquired via a global license agreement with Roche and Genentech. It has received FDA Breakthrough Therapy designation for pruritus associated with prurigo nodularis. - **KPL-404**: A clinical-stage asset for which Kiniksa has initiated a first-in-human study with an antigen challenge (TDAR). ## Market Standing - **Valuation/Market Cap**: Approximately $1.7 billion (as of mid-2026) - **Key Metric**: Annual Revenue of $677.6 million (as of mid-2026); Total Funding raised ~$80M in Series A and $170.7M in gross IPO proceeds (2018) - **Notable Investors/Partners**: Huadong Medicine (Asia Pacific collaboration), Roche, Genentech - **Growth Signals**: FDA approvals and breakthrough designations, expanding global footprint (UK, Switzerland, Netherlands offices), headcount of 310 employees and growing, active job postings (36 as of mid-2026) ## Competitive Advantages - **Approved Commercial Product**: ARCALYST® is the first and only FDA-approved therapy for recurrent pericarditis, creating a strong market foothold and revenue stream. - **Strong Pipeline**: Combination of FDA-approved therapy and clinical-stage assets with strong biologic rationale and validated pathways. - **Strategic Collaborations**: Partnerships with Roche/Genentech and Huadong Medicine provide access to global markets and cutting-edge science. - **Leadership**: Led by a team of distinguished life sciences leaders with over 30 years of combined industry experience. ## Strategic Focus - **Current priorities**: Commercializing ARCALYST® and expanding its indications; advancing the pipeline of clinical-stage assets (mavrilimumab, vixarelimab, KPL-404); expanding global presence (especially in Asia Pacific and Europe); pursuing further strategic acquisitions and collaborations. - **Patient-centric innovation**: Focus on immune modulation targeting unmet needs and underserved conditions. ## Why Work Here - **Culture**: Fosters a culture of passion, innovation, and rapid execution. Employees are described as "highly skilled, driven people advancing their careers—and making a difference in patients' lives." - **Commitment to employees**: Kiniksa is intentional about cultivating a highly skilled and passionate team determined to deliver on its promise to patients. - **Work environment**: Global company with offices in the US (Lexington, MA; La Jolla, CA), Switzerland (Zug), and the UK (London). The company offers a collaborative, science-driven environment. - **Diversity, Equity, and Inclusion**: Committed to creating a culture of equality that celebrates diversity and fosters innovation; an Equal Opportunity Employer. - **Perks & Benefits (US)**: - **Healthcare & Well-being**: Robust PPO medical insurance (Blue Cross Blue Shield) with HRA to cover deductible; dental (including orthodontia); vision; flexible spending accounts; fertility benefits and parental leave (up to 10 weeks at 100% pay, plus 6-8 weeks disability for birth parents); behavioral health support via EAP; and mental health programs. - **Financial & Protection**: 401k with traditional and Roth options through Fidelity, with immediate company match; Employee Stock Purchase Plan (15% discount); employer-paid life and AD&D insurance; short- and long-term disability coverage; voluntary additional life insurance. - **Work-Life Balance**: Paid sick and vacation time; company-paid holidays; company-sponsored events and volunteer opportunities. - **Other**: Subsidized lunches; employee referral program; starting coverage on the first day of employment. ## Sources 1. [Kiniksa Pharmaceuticals - About Us](https://www.kiniksa.com/about) 2. [Kiniksa Pharmaceuticals - Join Us](https://www.kiniksa.com/join-us) 3. [Kiniksa Pharmaceuticals - Leadership](https://www.kiniksa.com/leadership) 4. [Kiniksa Pharmaceuticals - LinkedIn Company Page](https://www.linkedin.com/company/kiniksa-pharmaceuticals) 5. 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