Director of Pharmacy Compliance Location:

Pittsburgh, PA Work Arrangement:

On-site Reports to: Chief Pharmacy Officer About the Role We are seeking an experienced Director of Pharmacy Compliance to lead pharmacy regulatory and compliance activities across the organization. This role will provide strategic oversight of pharmacy compliance, compounding operations, multistate licensing, regulatory risk, and inspection readiness. The ideal candidate is a licensed pharmacist with strong experience in pharmacy regulations, sterile and nonsterile compounding, and multistate pharmacy compliance. You will work closely with Pharmacy Operations, Quality, Clinical, Legal, and other leadership teams to ensure regulatory requirements are understood, implemented, and consistently followed. Key Responsibilities Lead and maintain the organization's pharmacy compliance and regulatory risk-management program. Monitor and interpret federal and state pharmacy laws, regulations, and regulatory guidance. Oversee compliance across multiple pharmacy locations and states. Maintain state pharmacy licenses, permits, registrations, pharmacist licenses, and renewal requirements. Provide regulatory oversight of sterile and nonsterile compounding operations. Ensure compliance with USP <795>, <797>, and <800> requirements. Support regulatory inspections, investigations, corrective action plans, and responses to regulatory inquiries. Develop and maintain pharmacy compliance policies, procedures, audits, and monitoring programs. Conduct compliance risk assessments and identify appropriate mitigation strategies. Partner with operational and executive leaders to address regulatory risks and compliance findings. Provide compliance education and training to pharmacy leaders and staff. Support FDA, DEA, and State Board of Pharmacy requirements and inspections. Maintain accurate regulatory documentation and an auditable compliance program. Qualifications Bachelor's degree required; BS Pharmacy or PharmD preferred. Minimum 5 years of progressive experience in pharmacy compliance, regulatory affairs, pharmacy law, risk management, or a related field. Active pharmacist license or eligibility for pharmacist licensure. Direct experience with sterile and nonsterile compounding. Strong knowledge of USP <795>, <797>, and <800>. Experience with pharmacy regulations across multiple states. Experience preparing for or responding to Board of Pharmacy or other regulatory inspections. Strong knowledge of pharmacy compliance, auditing, investigations, documentation, and risk management. Excellent communication and problem-solving skills with the ability to explain complex regulatory requirements to both operational and executive audiences. Preferred Experience Experience with 503A and/or 503B pharmacy-compounding requirements. Knowledge of FDA and DEA regulations and controlled-substance compliance. Experience with resident and nonresident pharmacy licensing. Experience opening, licensing, expanding, or supporting a compounding pharmacy. Healthcare compliance certification such as CHC, CHPC, or similar credential.

Pay:

$120,000.00 - $165,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person