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The job details are as follows:This role serves as a key leader in shaping and executing the Company's compliance audit and monitoring strategy. This role is responsible for both the strategic direction and operational delivery of the annual audit and monitoring plan, ensuring alignment with enterprise risk priorities and compliance objectives. The Director leads the identification, assessment, and prioritization of compliance risks and exercises independent judgment in determining audit scope, depth, and escalation pathways.
- Audit & Monitoring Plan Leadership: • 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
- Risk Identification & Assessment: • 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
- Audit Execution & Oversight: • 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
- Issue Management & Remediation: • 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
- Monitoring & Investigations Support: • 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
- Compliance Program Enablement: • 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
- Cross-Functional Collaboration: • 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
- Reporting & Continuous Improvement: • 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
Minimum 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
Preferred Qualifications
- Master's Degree in business, finance, life sciences or healthcare or
- Doctor of Philosophy (PhD) in business, finance, life sciences or healthcare
- 8+ years of experience with aggregating and analyzing structured and unstructured data including reporting and visualizing key risk/performance indicators
- Certified Compliance & Ethics Professional (CCEP) CCEP, or equivalent
- Certified Fraud Examiner (CFE)-ACFE CFE, or equivalent
- Certified Internal Auditor (CIA) CIA, or equivalent
This will be a home-based position, with a preference for candidates who are located on the eastern time zone. This position will have a travel requirement of 30% annually.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
