Manager, Compliance Operations
About this role
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.
Reporting to the VP, Head of Compliance, the Manager, Compliance Operations will serve an important role in the ongoing execution and continued enhancement of Kiniksa’s Compliance & Ethics program.
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):
- Assist in the development and planning of Kiniksa’s Compliance & Ethics auditing and monitoring plans to ensure Company compliance with applicable laws, regulations, and Company policies.
- Conduct both live and desktop auditing and monitoring of Medical, Clinical, Commercial, and other departmental activities to ensure compliance with applicable laws, regulations, and Company policies.
- Track and report progress of Compliance & Ethics auditing and monitoring plans, including drafting reports, communicating results, analyzing data, and supporting data analytics.
- Review Needs Assessment Forms (NAFs), including review of any proposed consulting engagements and assessment of Fair Market Value (FMV) requirements.
- Assist with identification and escalation of compliance or ethics issues or allegations which may require investigation, including supporting investigations and assisting with the management of the Company’s Ethics Hotline.
- Provide leadership in helping Kiniksa maintain and further develop a strong culture of compliance and ethics, including driving personal accountability for compliance and ethics.
- Maintain awareness and application of applicable laws, regulations and leading practices for compliance and ethics, and identify opportunities to enhance Kiniksa’s Compliance & Ethics program.
Standout Skills for Impact:
Compliance Audit & Monitoring Expertise
- Drives execution of risk-based auditing and monitoring plans across Medical, Clinical, and Commercial functions to ensure adherence to global regulations and company policies.
Road Warrior Mindset
- Thrives in a high-travel (up to 50%) environment, effectively conducting live audits and building strong on-the-ground relationships across teams.
Regulatory & Risk Intelligence
- Deep knowledge of pharma compliance frameworks (AKS, anti-bribery, OIG guidance, transparency reporting) with the ability to proactively identify and escalate risks.
Data-Driven Insights & Reporting
- Transforms audit findings into actionable insights through reporting, data analysis, and trend identification to strengthen the compliance program.
Investigations & Ethics Culture Champion
- Supports investigations, manages hotline activity, and reinforces a culture of integrity, accountability, and ethical decision-making.
Stakeholder Influence & Cross-Functional Collaboration
- Partners effectively across departments to communicate findings, influence outcomes, and align on remediation strategies.
Process Improvement & Program Development
- Continuously enhances compliance programs, monitoring strategies, and policies to align with evolving regulations and industry best practices.
Qualifications and Experience:
- 4+ years in compliance, ethics, audit, monitoring and/or other related experience with biotechnology, pharmaceutical or medical device companies.
- Experience developing and executing compliance and ethics auditing and monitoring activities.
- B.A./B.S. degree or equivalent required.
- Certified Fraud Examiner (CFE), Certified Internal Auditor (CIA), Certified in Healthcare Compliance (CHC), or Project Management Professional (PMP) a plus.
- Knowledge of, and experience with, laws, regulations, and industry guidance that affect the pharmaceutical industry, including but not limited to fraud, waste and abuse regulations, anti-kickback and anti-bribery laws, U.S. Department of Health and Human Services OIG guidelines, transparency and aggregate spend reporting requirements, government settlements (e.g., Corporate Integrity Agreements, Deferred Prosecution Agreements), and state marketing and price reporting compliance laws.
- Strong attention to detail and high-quality work product.
- Project management experience and strong problem-solving skills.
- Ability to work in a fast paced-environment and to handle multiple tasks.
- Track record and commitment to highest compliance and ethical standards.
- Proficient with Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint, etc.), as well as previous significant experience using report building software (e.g., Tableau, Smartsheet, Cognos Report, Query Studio)
- Ability to travel up to 50%.
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.
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