Manager, Compliance Operations
Kiniksa Pharmaceuticals
| Company | Kiniksa Pharmaceuticals |
| Category | Operations & Admin |
| Location | Lexington |
| Remote | On-site (inferred) |
| Employment | Not stated |
| Level | Manager |
| Salary | Not stated by the employer |
| Posted | 4 May 2026 |
| Last verified | 30 Jul 2026 |
| Source | Employer career page (greenhouse) |
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.
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:
Thrives in a high-travel (up to 50%) environment, effectively conducting live audits and building strong on-the-ground relationships across teams.
Deep knowledge of pharma compliance frameworks (AKS, anti-bribery, OIG guidance, transparency reporting) with the ability to proactively identify and escalate risks.
Transforms audit findings into actionable insights through reporting, data analysis, and trend identification to strengthen the compliance program.
Supports investigations, manages hotline activity, and reinforces a culture of integrity, accountability, and ethical decision-making.
Partners effectively across departments to communicate findings, influence outcomes, and align on remediation strategies.
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 a