Director of Pharmacy Compliance & Risk
On-sitePittsburgh, Pennsylvania, United States
Job Summary
Develop and oversee the enterprise pharmacy compliance and regulatory risk-management program, including monitoring federal and state laws, maintaining a comprehensive requirements matrix, and conducting enterprise risk assessments. Provide comprehensive regulatory oversight for sterile and nonsterile compounding operations, ensuring adherence to USP Chapters <795>, <797>, and <800>, while establishing policies, standard operating procedures, and conducting routine audits of facilities and personnel practices. Lead the organization's multistate pharmacy regulatory strategy by managing resident and nonresident licenses, evaluating state-specific requirements, and coordinating applications and renewals across jurisdictions. Identify legal, regulatory, and patient-safety risks, maintain an enterprise risk register, and lead investigations into potential violations to implement corrective actions.
Required Qualifications
- Bachelor of Science in Pharmacy or Doctor of Pharmacy degree from an accredited institution
- Active pharmacist license in good standing
- Eligibility for pharmacist licensure in the organization's primary operating state
- Minimum of five years of progressive experience in pharmacy compliance, regulatory affairs, pharmacy law, risk management, or a closely related field
- Direct regulatory or operational experience with sterile and nonsterile compounding
- Demonstrated knowledge of USP Chapters <795>, <797>, and <800>
- Working knowledge of FDA pharmacy-compounding requirements, including Section 503A of the Federal Food, Drug, and Cosmetic Act
- Demonstrated experience interpreting and applying pharmacy requirements across multiple states
- Experience with resident and nonresident pharmacy licensure
- Experience preparing for or responding to Board of Pharmacy or other regulatory inspections
- Demonstrated ability to develop policies, compliance controls, risk assessments, and auditing programs
- Strong investigation, documentation, analytical, and problem-solving skills
- Ability to communicate complex regulatory requirements clearly to operational and executive audiences
- Ability to work collaboratively across pharmacy operations, clinical services, technology, quality, legal, and business leadership
Desired Qualifications
- Three years of pharmacy compliance or regulatory leadership experience
- Experience establishing, opening, licensing, or expanding a compounding pharmacy
- Experience overseeing pharmacy compliance in a complex multistate organization
- Experience with both 503A compounding pharmacies and 503B outsourcing facilities
- Knowledge of DEA requirements and controlled-substance compliance
- Experience with FDA, DEA, or state Board of Pharmacy investigations
- Experience qualifying bulk-drug substance suppliers, API suppliers, laboratories, or other compounding-related vendors
- Experience developing compliance programs for new or rapidly growing pharmacy services
- Healthcare compliance certification, such as CHC, CHPC, or another relevant credential
- Advanced education or training in pharmacy law, regulatory affairs, compliance, or risk management
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