Executive Director - Compliance

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The Executive Director - Compliance leads the US Compliance program and team, ensuring adherence to healthcare laws, regulations and industry standards while enabling growth. This person will strategically partner with and advise senior management and the teams of Pharming Healthcare, Inc., embedding compliance into business strategy, decision-making and company culture. This role combines strategic leadership with hands-on execution.

This role can be based in our Warren, NJ office (with a hybrid work schedule), but we are also open to fully remote candidates who meet the required and preferred qualifications and are able to travel to the NJ office on at least a quarterly basis in addition to the other travel required for the position.

Responsibilities

• Lead the design, implementation, monitoring, and evolution of the U.S. Compliance program, including policies, procedures, trainings, and development and implementation of internal controls.
• Coach and lead the U.S. Compliance team (currently 1 direct report).
• Serve as a strategic business partner and trusted advisor to senior leadership and other functional teams, providing pragmatic guidance that balances risk and facilitates compliant growth.
• Promote a culture of integrity, accountability, and patient-centric decision-making.
• Partner with global Compliance colleagues to harmonize company-wide policies, procedures, and training, based on U.S. requirements and evolving business needs.
• Conduct periodic risk assessments, analyze trends and root causes, develop mitigation strategies across key areas, and track outcomes to help ensure continuous improvement.
• Leverage technology-enabled monitoring and data analytics tools, where applicable, to enhance risk detection.
• Review, assess risk, and advise on business programs and activities related to interactions with healthcare stakeholders to ensure compliance with U.S. policies, requirements and best practices.
• Chair the US Compliance Committee.
• Support process reviews and improvements in alignment with Pharming’s Global Compliance strategies.
• In coordination with other functions including Legal and Human Resources, conduct compliance-related investigations in the U.S.
• Report on an as-needed basis to the Board of Directors and/or relevant committees on healthcare compliance risks in the US.
• Continuously educate U.S.
  
  -based employees on matters related to the compliance program and related industry developments, including through trainings, internal communications, and the U.S. Compliance Intranet page.
• Implement KPIs, create dashboards and report to senior management and as needed, the Board of Directors.
• Other duties as assigned.

Qualifications

• Bachelor’s Degree plus compliance certification or equivalent professional education.
• Minimum of 10 years of experience in US pharmaceutical compliance roles; exposure to global pharmaceutical compliance preferred.
• In-depth knowledge and experience with US laws (e.g., Anti-Kickback Statute, False Claims Act, FDA promotional regulations, Sunshine Act /Open Payments and state transparency laws), policies, standards, financial or auditing practices in healthcare compliance.
• Familiarity with relevant industry and trade associations, their codes and related policies.
• Ability to lead and implement complex, multi-faceted projects and related compliance systems involving multiple stakeholders and functions.
• Ability to travel as needed for training, monitoring, company-wide meetings, and other stakeholder collaboration (up to 20%).
• Demonstrated experience building and implementing compliance programs preferred.
• Commitment and alignment to Pharming’s vision and values.

Who we are

We’re built on a simple belief: people living with rare diseases deserve more. Pharming is a global biotechnology company taking on some of the toughest rare disease challenges. We develop and commercialize innovative therapies for rare and ultra-rare immunological and genetic diseases with significant unmet need, where our scientific and commercial expertise, long-term commitment, and real partnership can help advance care.

We put patients at the heart of our…