---
title: 'Assoc. Director, Quality Management Systems at Kiniksa Pharmaceuticals'
canonical: 'https://feeny.ai/job/assoc-director-quality-management-systems-kiniksa-pharmaceuticals-lexington-sgeh0ans7am4'
type: 'job'
last_seen: '2026-10-12'
---

# Assoc. Director, Quality Management Systems at Kiniksa Pharmaceuticals

- **Company:** Kiniksa Pharmaceuticals
- **Location:** Lexington, MA
- **Compensation:** $186k–$200k
- **Posted:** 2026-10-07
- **Last confirmed live:** 2026-10-12
- **Apply:** https://job-boards.greenhouse.io/kiniksapharmaceuticals/jobs/4436975009

## 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 Associate Director, Quality Management Systems (QMS) is responsible for the site's GxP quality systems, including Document Control, Records Management, and Exceptions Management (Deviations, CAPAs, Change Controls, and Investigations/OOS). Reporting to the Director, Quality Management Systems, this role serves as Business Administrator and subject matter expert for the associated electronic systems, providing first-line user support and ensuring alignment with company policies and regulatory requirements. The Associate Director also identifies improvement opportunities and leads process enhancements.

Success in this role depends on reliable execution, efficient processes, and transparent reporting, both within Quality and to Senior Management.

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):

Under direction from, and in collaboration with the Director, Quality Management Systems, the Associate Director, QMS will:

Systems and Administration

- Contribute to the roadmap and continued maturity of the eQMS, including upgrades and configuration changes.
- Serve as subject matter expert and Business Administrator for the eQMS and eDMS, including user account management, pick list maintenance, and other administrative functions. Verify required training is complete before granting access.
- Provide training and first-line support to system users, and partner with IT to resolve issues and implement enhancements.

Quality Process Oversight

- Administer the deviation, CAPA, investigation, complaint, and change control processes in the eQMS, supporting event owners and tracking progress to meet closure targets.
- Lead weekly meetings to review open quality events and drive timely closure.
- Develop and implement Quality procedures that ensure consistency and compliance.

Training and Awareness

- Promote the requirements and capabilities of the eQMS and eDMS across the organization, and ensure exception owners, reviewers, approvers, document authors, and document reviewers are properly trained and supported.

Metrics and Reporting

- Facilitate Quality Management Review meeting on compliance status.
- Produce, trend, and publish Quality metrics that show performance against requirements, and identify ways to streamline analysis and communication.

Records Management

- Oversee the GxP records lifecycle, including retention, archival, and retrieval of paper and electronic records.

Inspection Readiness

- Participate in inspection readiness activities and provide back-room support during inspections. Serve as subject matter expert for document management and exceptions and interact with regulatory inspectors as needed.

Qualifications and Experience:

- Bachelor's degree (scientific or technical field preferred, or equivalent experience) and 8+ years of experience in Quality Systems within pharmaceutical, biotech, medical device, or another GxP-regulated environment.
- Hands-on experience as a business administrator for an eQMS and an eDMS (document control, deviations, CAPA, change control).
- Experience writing and maintaining Quality procedures.
- Working knowledge of GxP and ICH requirements, including electronic records and signatures (e.g., 21 CFR Part 11), and of exceptions management and records management processes.
- Experience collaborating with IT on system enhancements, upgrades, or validation.
- Experience producing, trending, and presenting quality metrics to senior leadership.
- Experience supporting regulatory inspections or audits, including back-room or SME roles.
- Strong project management, presentation, and facilitation skills, including leading cross-functional meetings.
- Demonstrated ability to influence and drive accountability across teams without direct authority.
- Ability to work independently and within a team structure.
- Excellent written, verbal, and interpersonal communication skills.
- Proficiency with Veeva Quality applications (QMS and QualityDocs).
- Proficiency with Microsoft Office, including Excel.

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

Pay Range $186,000—$200,000 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. [Kiniksa Pharmaceuticals - Main Site](https://www.kiniksa.com/)

## Other roles at Kiniksa Pharmaceuticals

- [Assoc. Director, Clinical Quality Assurance](https://feeny.ai/job/assoc-director-clinical-quality-assurance-kiniksa-pharmaceuticals-lexington-0qmsbr1k9dfj) — Lexington, MA
- [Clinical Sales Specialist-Phoenix](https://feeny.ai/job/clinical-sales-specialist-phoenix-kiniksa-pharmaceuticals-phoenix-w7rensy8mm79) — Phoenix, AZ
- [Clinical Sales Specialist-Tucson](https://feeny.ai/job/clinical-sales-specialist-tucson-kiniksa-pharmaceuticals-tucson-zgq19bbc9pr2) — Tucson, AZ
- [Clinical Sales Specialist- San Jose](https://feeny.ai/job/clinical-sales-specialist-san-jose-kiniksa-pharmaceuticals-field-tkgmyvb7w4hz) — Field
- [Clinical Sales Specialist- Southern Colorado](https://feeny.ai/job/clinical-sales-specialist-southern-colorado-kiniksa-pharmaceuticals-field-0av43m0vtzxt) — Field
- [Clinical Sales Specialist- Kentucky](https://feeny.ai/job/clinical-sales-specialist-kentucky-kiniksa-pharmaceuticals-field-38zz57hg9k0p) — Field
- [Director, Medical Writing](https://feeny.ai/job/director-medical-writing-kiniksa-pharmaceuticals-lexington-87fpdgh3y7c4) — Lexington, MA
- [CMC Project Manager](https://feeny.ai/job/cmc-project-manager-kiniksa-pharmaceuticals-lexington-vwrkbs252sf5) — Lexington, MA
- [Manager, Medical Review & Communications, Global Medical Affairs](https://feeny.ai/job/manager-medical-review-communications-global-medical-affairs-kiniksa-abcmwczpw4am) — Lexington, MA
- [Sr. Director, Clinical Supply Chain Management and Systems](https://feeny.ai/job/sr-director-clinical-supply-chain-management-and-systems-kiniksa-8szgtwx1s3fm) — Lexington, MA