Corporate Compliance Director - Auditing

Unither Pharmaceuticals•RTP, NC, NC

5d•Remote

About The Position

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.

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

Nice To Haves

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

Responsibilities

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