Director, Healthcare Compliance

Aquestive Therapeutics•Warren, NJ

About The Position

The Director, Healthcare Compliance is responsible for leading and operating the Company's healthcare compliance program and promoting a culture of ethics, integrity, and compliance across the organization. Reporting to the Chief Legal Officer & Chief Compliance Officer, this position serves as the Company's primary healthcare compliance leader and strategic advisor to Commercial, Medical Affairs, Market Access, Patient Services, Regulatory Affairs, and other business functions. The Director is responsible for designing, implementing, monitoring, and continuously improving an effective healthcare compliance program consistent with OIG Compliance Program Guidance, applicable federal and state healthcare laws, FDA regulations, industry codes, and Company policies. This is a highly visible, hands-on leadership role responsible for executing key aspects of the compliance program, including risk assessment, training, monitoring, investigations, transparency reporting, and compliance governance. The Director will partner closely with business leaders across the organization and may oversee compliance personnel and external resources as the function evolves. The Director will work closely with the Associate General Counsel on healthcare regulatory matters, investigations, policy development, compliance monitoring activities, and legal-compliance risk assessments. This role is designed to be the Company's senior healthcare compliance leader and primary compliance subject matter expert. The position combines strategic oversight with direct operational responsibility and requires a professional who can independently build, implement, monitor, and continuously improve an effective healthcare compliance program. Success in the role will depend on sound judgment, strong cross-functional influence, deep healthcare compliance expertise, and a willingness to operate as a hands-on leader while helping scale the compliance function as the organization grows.

Requirements

Bachelor's degree required.
10+ years of pharmaceutical, biotechnology, healthcare, or healthcare compliance experience.
5+ years leading healthcare compliance programs, initiatives, or teams in a pharmaceutical, biotechnology, or healthcare organization.
Deep expertise in FDA promotional regulations, Anti-Kickback Statute, False Claims Act, Sunshine/Open Payments, OIG Compliance Program Guidance, PhRMA Code, and State healthcare compliance requirements.
Experience leading audits, investigations, training, monitoring, and compliance risk management programs.
Significant MLR review experience.
Demonstrated ability to independently build, implement, and operate healthcare compliance programs in a pharmaceutical, biotechnology, or healthcare environment.
Strong business partnering, communication, and influencing skills with demonstrated ability to engage effectively with executive leadership and cross-functional stakeholders.
Proven ability to manage multiple priorities in a dynamic growth environment.

Nice To Haves

JD, MBA, PharmD, MSN, or equivalent advanced degree preferred.

Responsibilities

Lead all aspects of the healthcare compliance program.
Develop and execute annual healthcare compliance strategy and work plan.
Conduct enterprise healthcare compliance risk assessments.
Maintain compliance policies, standards, procedures, and controls.
Develop compliance metrics and key performance indicators.
Administer Healthcare Compliance Committee activities.
Prepare reports for Executive Leadership, Compliance Committee, and Board committees.
Escalate significant compliance risks and investigations.
Serve as the primary compliance advisor to the Chief Compliance Officer and provide regular updates regarding compliance program effectiveness, emerging risks, investigations, and remediation activities.
Serve as a core member of the MLR review process.
Advise on promotional materials and promotional claims.
Support launch and lifecycle compliance activities.
Provide guidance regarding speaker programs, advisory boards, consultants, grants, charitable contributions, sponsorships, and other healthcare professional engagement activities.
Provide oversight of Anti-Kickback Statute compliance, False Claims Act risk mitigation, Sunshine/Open Payments reporting, State transparency laws, Fair Market Value (FMV) assessments, Needs assessments, and Engagement documentation and controls.
Develop annual monitoring plan.
Conduct and oversee monitoring reviews.
Recommend and track corrective action plans.
Analyze trends and emerging compliance risks.
Lead healthcare compliance investigations.
Partner with Human Resources and Legal, when appropriate.
Ensure appropriate documentation, remediation, and CAPAs.
Create risk-based compliance training programs.
Deliver live training to commercial, medical, and cross-functional teams.
Maintain compliance communications and awareness initiatives.
Serve as a hands-on compliance leader responsible for both strategy development and program execution.
Personally conduct and oversee key compliance activities, including risk assessments, monitoring, investigations, training, and governance reporting.
Influence and lead cross-functional stakeholders without direct reporting authority.
Coordinate external advisors and consultants to support specialized compliance initiatives.
Build and scale the healthcare compliance function and team as business needs evolve.