Overview:
Director of Pharmacy Compliance
Location: Pittsburgh, PA
Work Arrangement: On-site
Reports to: Chief Pharmacy Officer
The Opportunity
Grane Rx is seeking an experienced pharmacy compliance leader to serve as our Director of Pharmacy Compliance. This key leadership position will provide comprehensive regulatory oversight across all of our pharmacy locations, with significant responsibility for sterile and nonsterile compounding and multistate pharmacy compliance.
The ideal candidate is a licensed pharmacist with extensive knowledge of pharmacy regulations, compounding standards, risk management, and regulatory frameworks across multiple states. This individual must be able to interpret complex requirements and translate them into practical, sustainable operating processes.
This position offers an opportunity to build and lead a comprehensive pharmacy compliance program while supporting the organization’s continued growth and expansion
Responsibilities:
Key Responsibilities
Enterprise Pharmacy Compliance
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Develop, implement, and oversee the organization’s pharmacy compliance and regulatory risk-management program.
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Monitor federal and state pharmacy laws, regulations, standards, and regulatory guidance.
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Maintain a comprehensive regulatory requirements matrix for each state in which the organization operates or holds licensure.
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Evaluate new and changing state requirements and determine their operational impact.
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Advise executive and operational leaders regarding pharmacy compliance obligations and emerging regulatory risks.
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Conduct enterprise compliance risk assessments and develop appropriate mitigation strategies.
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Establish compliance monitoring, auditing, reporting, and escalation processes.
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Oversee regulatory investigations, corrective action plans, and responses to identified compliance concerns.
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Partner with Quality, Operations, Clinical, Informatics, Pharmacy Services, Human Resources, and Legal Counsel to integrate compliance requirements into business processes.
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Support state Board of Pharmacy, FDA, DEA, and other regulatory inspections and inquiries.
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Develop compliance education and training for pharmacy leaders and team members.
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Maintain compliance policies, regulatory documentation, licenses, permits, and evidence of organizational adherence.
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Conduct routine compliance audits and self-assessments.
Compounding Compliance and Oversight
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Provide comprehensive regulatory oversight for sterile and nonsterile compounding operations.
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Ensure compliance with applicable federal requirements, state pharmacy laws, Board of Pharmacy regulations, and USP compounding standards.
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Oversee organizational compliance with USP Chapters <795>, <797>, and <800>.
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Establish and maintain compounding policies, standard operating procedures, controls, and documentation requirements.
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Assess facility design, engineering controls, cleanroom operations, environmental monitoring, and workflow for regulatory compliance.
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Oversee compliance requirements related to beyond-use dating, stability information, formulation records, master formulation records, compounding records, labeling, packaging, storage, and distribution.
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Ensure appropriate controls for hazardous drugs, including receipt, storage, compounding, dispensing, transportation, spill management, and disposal.
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Oversee recall readiness and coordinate regulatory reporting and response activities when required.
Multistate Pharmacy Compliance
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Lead the organization’s multistate pharmacy regulatory strategy.
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Maintain oversight of resident and nonresident pharmacy licenses, permits, registrations, pharmacist licenses, pharmacist-in-charge requirements, and renewal deadlines.
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Identify differences among state requirements for compounding, dispensing, labeling, counseling, shipping, controlled substances, record retention, and reporting.
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Maintain an auditable system of licensure, regulatory filings, inspection findings, corrective actions, and supporting documentation.
Pharmacy Risk Management
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Identify legal, regulatory, patient-safety, financial, and reputational risks across pharmacy operations.
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Maintain an enterprise pharmacy compliance risk register.
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Establish key compliance indicators and provide regular reports to executive leadership.
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Perform root-cause analysis and trend compliance findings across locations and business lines.
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Help foster a culture in which compliance, patient safety, and ethical decision-making are integrated into daily operations.
Qualifications:
Required Qualifications
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A strategic thinker who anticipates regulatory risks and recommends practical solutions.
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Comfortable building programs and establishing consistent standards across multiple locations and states.
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Highly knowledgeable and detail-oriented without losing sight of broader organizational priorities.
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Decisive and confident when regulatory requirements are unclear or differ among jurisdictions.
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Collaborative and capable of translating complex requirements into effective operating processes.
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Willing to respectfully challenge decisions when compliance or patient safety could be compromised.
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Committed to patient safety, ethical conduct, accountability, and continuous improvement.
Why Join Grane Rx?
This position offers the opportunity to shape and lead pharmacy compliance across a growing and increasingly complex organization. The Director of Pharmacy Compliance & Risk will have a meaningful role in establishing regulatory strategy, strengthening compounding oversight, supporting multistate operations, and creating a sustainable compliance infrastructure for future growth.
Equal Employment Opportunity
Grane Rx is an equal opportunity employer. We are committed to creating an inclusive workplace and consider qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law.
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