Job Description:
• Lead the development, execution, and continuous enhancement of the annual compliance audit and monitoring plan
• Translate compliance risk priorities into actionable audit strategies and defined monitoring activities
• Oversee and review the work of contractors and temporary associates, as needed
• Identify, assess, and prioritize compliance risks across business functions
• Partner with stakeholders to ensure risk-based audit coverage aligned to applicable regulatory requirements and internal policies
• Plan, coordinate, and conduct audits to evaluate adherence to FDA regulations, healthcare fraud and abuse laws, industry codes, and Company standards
• Oversee end-to-end audit lifecycle, including scoping, fieldwork, documentation, reporting, and follow-up
• Develop and maintain audit trackers and reporting tools to ensure timely identification, escalation, and resolution of findings
• Partner with business stakeholders to define corrective action plans and monitor remediation through closure
• Support ongoing compliance monitoring activities and contribute to internal investigations as needed
• Ensure alignment between audit findings, monitoring insights, and investigative outcomes to strengthen controls
• Serve as a subject matter expert on healthcare compliance requirements, ensuring consistent application across audit and monitoring activities
• Maintain and optimize compliance systems and tools that support tracking, documentation, and reporting
• Collaborate with Legal, Risk Management, Finance, and business teams to drive compliance objectives and reinforce a culture of accountability
• Provide guidance and training to stakeholders on audit expectations and compliance requirements
• Prepare and deliver audit results, trend analyses, and risk insights to senior leadership
• Identify opportunities to enhance internal controls, audit methodologies, and overall program effectiveness
• Perform other departmental duties as assigned
Requirements:
• Bachelor’s Degree in business, finance, life sciences or healthcare
• 15+ years of compliance experience within the life sciences industry (pharmaceutical, medical device, or biotech) with a Bachelor's Degree or 13+ years of compliance experience within the life sciences industry (pharmaceutical, medical device, or biotech) with a Master's Degree or 10+ years of compliance experience within the life sciences industry (pharmaceutical, medical device, or biotech) with a PhD
• 10+ years of experience in corporate compliance auditing, monitoring, and/or investigations
• Advanced knowledge of healthcare compliance regulations including AKS, FCA, HIPAA, FCPA, and Sunshine Act
• Ability to lead and influence cross-functional stakeholders without direct authority
• Demonstrated independent judgment in risk prioritization and issue escalation
• Expertise in audit, monitoring, and internal control frameworks
• Strong data analysis and reporting capabilities, including development of risk indicators
• Excellent written and verbal communication skills with executive presence
• Ability to present complex compliance issues to senior leadership
• Strong collaboration and stakeholder management skills
• High level of integrity, discretion, and professional judgment
• Ability to manage multiple priorities and drive projects to completion
• Proficiency in Microsoft Office and compliance tools such as Power BI, Veeva, and SharePoint
Benefits:
• medical / dental / vision / prescription coverage
• employee wellness resources
• savings plans (401k and ESPP)
• paid time off & paid parental leave benefits
• disability benefits