Director of Pharmacy Compliance

About the Role

As the Director of Pharmacy Compliance, you will play a critical role in ensuring the safety, quality, and compliance of our pharmacy operations. Leveraging your expertise in sterile compounding and regulatory frameworks, you will develop, implement, and oversee policies that align with state, federal, and industry standards. This leadership position offers the opportunity to shape the compliance strategy for a growing, dynamic team, all while working in a fully remote environment.

What You’ll Do

• Lead compliance efforts related to sterile compounding and overall pharmacy operations, ensuring adherence to USP, FDA, and state-specific regulations.
• Develop and maintain comprehensive compliance programs, including audits, risk assessments, and corrective action plans.
• Collaborate with cross-functional teams, including clinical and operational staff, to establish best practices and enhance quality assurance.
• Monitor changes in regulatory requirements and proactively update company policies and training materials.
• Act as the primary liaison with regulatory bodies and accreditation organizations, preparing reports and addressing compliance inquiries.
• Conduct training sessions for staff to ensure understanding and adherence to compliance standards.
• Oversee investigations related to compliance breaches and lead efforts to implement effective resolutions.

Who You Are

• PharmD required with an active and unrestricted pharmacist license.
• Extensive experience in sterile compounding, with a deep understanding of USP <797> and <800>.
• Proven track record of developing and managing pharmacy compliance programs.
• Strong knowledge of federal and state pharmacy laws and regulations.
• Exceptional organizational and communication skills, with the ability to lead and mentor teams remotely.
• Analytical and detail-oriented, with a proactive approach to problem-solving.

Nice to Have

• Experience working in a start-up or growth-stage company.
• Familiarity with technology-driven pharmacy operations or telepharmacy.
• Advanced certifications in sterile compounding or pharmacy compliance.
• Experience with electronic health records (EHR) systems or other healthcare technology platforms.