Overview

Director of Pharmacy Compliance & Risk

 

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 & Risk. 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.

· Advise executive and operational leaders regarding pharmacy compliance obligations and emerging regulatory risks.

· 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.

 

Compounding Compliance and Oversight

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

· Ensure compliance with applicable federal requirements, state pharmacy laws, Board of Pharmacy regulations, and USP compounding standards.

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

· Evaluate the applicability of Section 503A requirements and any potential 503B considerations.

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

· Conduct routine compliance audits of compounding facilities, processes, records, and personnel practices.

· Assess facility design, engineering controls, cleanroom operations, environmental monitoring, and workflow for regulatory compliance.

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

· Monitor compliance with requirements governing bulk-drug substances, active pharmaceutical ingredients, components, and finished preparations.

· Establish regulatory qualification and oversight requirements for suppliers, laboratories, equipment vendors, and outsourced service providers.

· Review compounding formulas, processes, and proposed product offerings for regulatory risk before implementation.

· Establish formal compliance approval checkpoints for new compounded preparations, services, facilities, equipment, and markets.

· Oversee required personnel training, competency assessments, garbing qualifications, aseptic technique evaluations, and documentation.

· Monitor environmental sampling, certification, testing, cleaning, and maintenance requirements.

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

· Develop processes for investigating compounding deviations, out-of-specification results, environmental excursions, complaints, adverse events, and product-quality concerns.

· Oversee recall readiness and coordinate regulatory reporting and response activities when required.

· Remain current on FDA safety communications, drug-shortage requirements, bulk-substance restrictions, enforcement activity, and changes in compounding standards.

 

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.

· Evaluate state-specific requirements before the organization begins dispensing or distributing medications into a new state.

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

· Develop state-specific policies or operational controls when a single enterprise standard does not satisfy all applicable requirements.

· Coordinate applications, renewals, notifications, ownership disclosures, pharmacist-in-charge changes, and other regulatory submissions.

· Prepare pharmacy locations and leaders for resident-state and nonresident-state inspections.

· Monitor state Board of Pharmacy meeting minutes, regulatory notices, disciplinary actions, and proposed or enacted rule changes.

· Evaluate how regulatory changes affect pharmacy systems, workflows, staffing, documentation, and patient services.

· Partner with operational leaders to implement regulatory changes within required timeframes.

· 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.

· Establish key compliance indicators and provide regular reports to executive leadership.

· Lead investigations into potential regulatory violations and oversee corrective and preventive actions.

· Perform root-cause analysis and trend compliance findings across locations and business lines.

· Coordinate with internal and outside legal counsel on specialized pharmacy regulatory matters.

· Establish confidential processes for reporting and escalating potential compliance concerns.

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

Qualifications

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.

 

Preferred 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.

 

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.

 

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.