Kiniksapharmaceuticals

Manager, Compliance Operations

Lexington, MA

Sponsorship not specified$128k-$140kDetected 22 days ago

Data AnalysisData VisualizationProject ManagementExcelAuditingFDA RegulatoryMedical DevicesLeadershipProblem SolvingMicrosoft OfficeSharePoint

About the role

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.

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.
Thrives in a high-travel (up to 50%) environment, effectively conducting live audits and building strong on-the-ground relationships across teams.
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.
Experience developing and executing compliance and ethics auditing and monitoring activities.
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)

$128,000 - $140,000 USD
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.

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.
4+ years in compliance, ethics, audit, monitoring and/or other related experience with biotechnology, pharmaceutical or medical device companies.
Certified Fraud Examiner (CFE), Certified Internal Auditor (CIA), Certified in Healthcare Compliance (CHC), or Project Management Professional (PMP) a plus.
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

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.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

This listing is sourced directly from Kiniksapharmaceuticals's careers page and normalized into a canonical job model.