Director of Pharmacy Compliance

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

 

· Develop, implement, and oversee the organization’s pharmacy compliance and regulatory risk-management program.

· Monitor federal and state pharmacy laws, regulations, standards, and regulatory guidance.

· Maintain a comprehensive regulatory requirements matrix for each state in which the organization operates or holds licensure.

· Evaluate new and changing state requirements and determine their operational impact.

· Conduct enterprise compliance risk assessments and develop appropriate mitigation strategies.

· Establish compliance monitoring, auditing, reporting, and escalation processes.

· Oversee regulatory investigations, corrective action plans, and responses to identified compliance concerns.

· Partner with Quality, Operations, Clinical, Informatics, Pharmacy Services, Human Resources, and Legal Counsel to integrate compliance requirements into business processes.

· Support state Board of Pharmacy, FDA, DEA, and other regulatory inspections and inquiries.

· Develop compliance education and training for pharmacy leaders and team members.

· Maintain compliance policies, regulatory documentation, licenses, permits, and evidence of organizational adherence.

· Conduct routine compliance audits and self-assessments.

Compounding Compliance and Oversight

· Provide comprehensive regulatory oversight for sterile and nonsterile compounding operations.

· Oversee organizational compliance with USP Chapters <795>, <797>, and <800>.

· Establish and maintain compounding policies, standard operating procedures, controls, and documentation requirements.

· Oversee compliance requirements related to beyond-use dating, stability information, formulation records, master formulation records, compounding records, labeling, packaging, storage, and distribution.

· Ensure appropriate controls for hazardous drugs, including receipt, storage, compounding, dispensing, transportation, spill management, and disposal.

Multistate Pharmacy Compliance

· Lead the organization’s multistate pharmacy regulatory strategy.

· Maintain oversight of resident and nonresident pharmacy licenses, permits, registrations, pharmacist licenses, pharmacist-in-charge requirements, and renewal deadlines.

· Identify differences among state requirements for compounding, dispensing, labeling, counseling, shipping, controlled substances, record retention, and reporting.

· Maintain an auditable system of licensure, regulatory filings, inspection findings, corrective actions, and supporting documentation.

Pharmacy Risk Management

· Identify legal, regulatory, patient-safety, financial, and reputational risks across pharmacy operations.

· Maintain an enterprise pharmacy compliance risk register.

· Help foster a culture in which compliance, patient safety, and ethical decision-making are integrated into daily operations.

Qualifications

 

Required Qualifications

 

· Bachelor’s degree (or higher education) and minimum of five years of experience in pharmacy compliance, regulatory affairs, or a closely related field.

· Direct regulatory or operational experience with sterile and nonsterile compounding.

· Demonstrated knowledge of USP Chapters <795>, <797>, and <800>.

· Demonstrated experience interpreting and applying pharmacy requirements across multiple states.

· 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.

 

Preferred Qualifications

· Bachelor of Science in Pharmacy or Doctor of Pharmacy degree from an accredited institution.

· Three years of pharmacy compliance or regulatory leadership experience.

· Eligibility for pharmacist licensure in the organization’s primary operating state.

· Experience establishing, opening, licensing, or expanding a compounding pharmacy.

· Experience with resident and nonresident pharmacy licensure.

· Experience overseeing pharmacy compliance in a complex multistate organization.

· Working knowledge of FDA pharmacy-compounding requirements, including Section 503A of the Federal Food, Drug, and Cosmetic Act.

· 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 developing compliance programs for new or rapidly growing pharmacy services.

· Healthcare compliance certification, such as CHC, CHPC, or another relevant credential.

 

Leadership Attributes

The successful candidate will be:

· A strategic thinker who anticipates regulatory risks and recommends practical solutions.

· Comfortable building programs and establishing consistent standards across multiple locations and states.

· Highly knowledgeable and detail-oriented without losing sight of broader organizational priorities.

· Decisive and confident when regulatory requirements are unclear or differ among jurisdictions.

· Collaborative and capable of translating complex requirements into effective operating processes.

· Willing to respectfully challenge decisions when compliance or patient safety could be compromised.

· 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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