Position Overview:
The Compliance Director will lead and oversee all compliance and regulatory functions for Senderra Specialty Pharmacy, reporting directly to the General Counsel & Chief Compliance Officer. This senior leadership role ensures full adherence to federal and state pharmacy laws, DEA regulations, Medicare/Medicaid requirements, accreditation standards, and industry best practices. A key focus will be on pharmacy licensing across multiple states and managing Change of Ownership (CHOW) applications and processes for acquisitions, expansions, or ownership transitions. The ideal candidate is a strategic leader with deep expertise in specialty pharmacy operations, regulatory navigation, and risk management in a fast-growing, patient-focused environment.
Key Responsibilities:
· Develop, implement, and maintain a comprehensive compliance program tailored to specialty pharmacy operations, including policies, procedures, training, monitoring, and auditing to mitigate regulatory risks.
· Serve as the primary expert and point of contact for all pharmacy licensing matters, including initial applications, renewals, amendments, and multi-state expansions.
· Lead the preparation, submission, and management of Change of Ownership (CHOW) applications for pharmacy licenses, DEA registrations, Medicare/Medicaid provider enrollment, and related regulatory notifications in coordination with legal, operations, and executive teams.
· Monitor and interpret evolving federal (e.g., FDA, DEA, CMS) and state Board of Pharmacy regulations, accreditation standards (URAC, ACHC), and industry guidance; communicate impacts and implement necessary changes.
· Oversee internal audits, compliance risk assessments, and corrective action plans to ensure ongoing adherence and readiness for external audits or inspections.
· Collaborate with cross-functional teams (pharmacy operations, legal, finance, clinical, IT) to integrate compliance into daily workflows and support business growth initiatives.
· Manage relationships with state Boards of Pharmacy, regulatory agencies, accrediting bodies, and external auditors.
· Develop and deliver compliance training programs for staff at all levels, fostering a culture of integrity and regulatory awareness.
· Investigate and resolve compliance incidents, potential violations, or complaints; implement preventive measures.
· Stay ahead of emerging trends in specialty pharmacy compliance, including specialty medication handling, patient privacy (HIPAA), fraud/abuse prevention, and payer requirements.
· Prepare reports and presentations for the General Counsel & Chief Compliance Officer, executive leadership, and the Board on compliance status, risks, and mitigation strategies.
Qualifications:
· Education: Bachelor’s degree required
· Experience:
o Minimum 7+ years of progressive experience in a pharmacy setting (specialty pharmacy preferred), with direct involvement in regulatory compliance and licensing.
o Proven expertise in pharmacy licensing requirements across multiple states.
o Hands-on experience preparing and managing CHOW (Change of Ownership) applications and processes for pharmacies, including state Board of Pharmacy submissions, DEA notifications, and CMS enrollment changes.
o Prior leadership experience in compliance, regulatory affairs, or quality roles within a pharmacy or healthcare organization.
· Licenses/Certifications: Certified in Healthcare Compliance (CHC) or similar certification a plus.
· Knowledge & Skills:
o In-depth understanding of federal/state pharmacy laws, DEA regulations, HIPAA, CMS Conditions of Participation, and specialty pharmacy accreditation standards.
o Strong project management skills with the ability to handle complex, time-sensitive regulatory filings.
o Excellent analytical, communication, and interpersonal skills; ability to influence and collaborate at all organizational levels.
o Proficiency in compliance management tools, auditing software, and Microsoft Office Suite.
· Personal Attributes: Strategic thinker, detail-oriented, proactive, ethical, and able to thrive in a dynamic, growth-oriented environment.
Job Type: Full-time
Pay: $125,000.00 - $170,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Ability to Commute:
- Dallas, TX 75243 (Preferred)
Ability to Relocate:
- Dallas, TX 75243: Relocate before starting work (Preferred)
Work Location: Hybrid remote in Dallas, TX 75243
