Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · Remote OK
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Lexington, Massachusetts, United States · Hybrid
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Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · Remote OK
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Lexington, Massachusetts, United States · Hybrid
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Mimecast is a leading cybersecurity company transforming the way businesses manage and mitigate human risk. Its AI-powered, API-enabled connected human risk platform is purpose-built to protect organizations from the spe…
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Lexington, Massachusetts, United States · On-site
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Skills: CT Procedures, PACS, Image Manipulation, Human Anatomy, Pathology
Lexington, Massachusetts, United States · On-site
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Lexington, Massachusetts, United States · On-site
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Skills: Assay Data Analysis, Scientific Consulting, Software Demonstrations, Project Management, Technical Support
Lexington, Massachusetts, United States • On-site
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Provide strategic leadership and oversight of global quality compliance programs, ensuring alignment with regulatory requirements and industry best practices. Lead key quality systems including supplier oversight, product complaints, and inspection readiness to drive a proactive, risk-based quality culture.
Requires an advanced scientific degree and over 12 years of experience in Quality Assurance/Compliance within the pharmaceutical or biotechnology industry. Must have extensive experience with regulatory inspections, health authority interactions, and global regulatory guidelines such as FDA and EMA.
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.
We're seeking a Senior Director, Quality Compliance reporting to the VP, Head of Quality, who will be responsible for providing strategic leadership and oversight of the organization’s global quality compliance programs, ensuring alignment with regulatory requirements and industry best practices. This role leads key quality systems including supplier oversight, product complaints, and inspection readiness, and partners cross-functionally to drive a proactive, risk-based quality culture that supports development through commercialization.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
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.
Relentless. Passionate. Focused.
Kiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa’s portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. At Kiniksa, patients are at the heart of everything we do. Our Every Second Counts! mindset reflects our commitment to making a difference for people who are navigating the uncertainty and challenges of life-altering diseases. This is why our team is relentless in pursuing treatments that bring us closer to a better future for patients, every second of every day. We rely on an exceptional team to drive our mission of building a global, generational company. If you're passionate about making a meaningful impact, we’d love to hear from you. Kiniksa offers competitive benefits and dynamic career opportunities across our organization. We foster a culture of passion, innovation, and rapid execution to help fulfill our mission.
Offices: 100 Hayden Ave, Lexington, Massachusetts 02421, US · 105 Piccadilly, Second Floor, London, England W1J 7NJ, GB · Grafenaustrasse 5, Zug, ZG 6300, CH · 3366 N Torrey Pines Ct, #320, San Diego, California 92037, US
