Director of Pharmacy Operations, Quality & Compliance

ProCompounding Pharmacy; Johnson City (TN); Presencial; USD 150.000 - 210.000; Jornada completa

Descripción de la vacante

ProCompounding Pharmacy seeks an experienced pharmacist to provide senior leadership across pharmacy operations, quality systems, regulatory compliance, and both sterile and nonsterile compounding. The role is hands-on and focuses on strengthening infrastructure, developing people, and maintaining regulatory readiness to support growth.

The ideal candidate will have pharmacist licensure with significant 503A compounding experience, strong leadership in operations and quality, and familiarity

Formación

• Licensure as a Pharmacist.
• Experience leading pharmacy operations, quality, and compliance.
• Knowledge of sterile and nonsterile compounding operations.
• Familiarity with USP <795>, <797>, <800> requirements and inspections.
• Ability to translate regulatory requirements into practical processes.

Responsabilidades

• Provide leadership and oversight for pharmacy operations, quality, and regulatory compliance.
• Support sterile and nonsterile compounding operations and ensure alignment with standards and regulations.
• Maintain and continuously improve the pharmacy's quality management systems.
• Oversee compliance with USP <795>, <797>, and <800> requirements.
• Lead preparation for regulatory inspections, accreditation surveys, and internal quality reviews.
• Manage investigations, deviations, root-cause analysis, CAPA, and related quality initiatives.
• Develop practical policies, procedures, and operating systems for consistency and accountability.
• Coach and develop pharmacy team members and emerging leaders.
• Partner with ownership on operational priorities, risk management, and growth initiatives.
• Monitor regulatory developments and ensure multi-state compliance.

Conocimientos

Leadership

Regulatory compliance

Quality management

Operational excellence

Communication

Educación

Pharmacist licensure

BCSCP certification (preferred)

Descripción del empleo

ProCompounding Pharmacy is seeking an experienced pharmacist to provide

leadership across pharmacy operations, quality systems, regulatory compliance, and

sterile and nonsterile compounding.

This is a senior, hands-on leadership position for someone who understands both the

technical and operational demands of a growing 503A compounding pharmacy. The

successful candidate will help strengthen our pharmacy infrastructure, develop our

people, maintain regulatory readiness, and build practical systems that support quality,

consistency, and continued growth.

Key Responsibilities

The Director of Pharmacy Operations, Quality & Compliance will:

• Provide leadership and oversight for pharmacy operations, quality, and regulatory compliance.
• Support sterile and nonsterile compounding operations and ensure alignment with applicable standards and regulations.
• Maintain and continuously improve the pharmacy's quality management systems.
• Oversee compliance with USP <795>, <797>, and <800> requirements.
• Lead preparation for regulatory inspections, accreditation surveys, and internal quality reviews.
• Manage investigations, deviations, root-cause analysis, corrective and preventive actions, and related quality initiatives.
• Develop practical policies, procedures, and operating systems that improve consistency and accountability.
• Coach, develop, and support pharmacy team members and emerging leaders.
• Partner with ownership and leadership on operational priorities, risk management, and growth initiatives.
• Monitor regulatory developments and help ensure compliance across multiple states.

Ideal Background

Strong candidates will bring:

• Pharmacist licensure and significant experience within a 503A compounding pharmacy.
• Leadership experience involving pharmacy operations, quality, compliance, or staff management.
• Experience with both sterile and nonsterile compounding strongly preferred.
• Board Certification in Sterile Compounding Pharmacy (BCSCP) preferred.
• Working knowledge of USP <795>, <797>, and <800>
• Experience with inspections, accreditation, investigations, CAPA processes, and quality improvement.
• The ability to translate regulatory requirements into practical operating processes.
• Strong leadership, communication, documentation, and problem-solving skills.
• Experience working within a multistate pharmacy environment.

Experience in 503B outsourcing facilities, pharmaceutical manufacturing, or cGMP environments would be an additional advantage.

Multistate pharmacist licensure is not required.

The Opportunity

ProCompounding is a growing organization where senior leaders remain close to the

work. This position is well suited for someone who enjoys building systems, solving

problems, developing people, and taking ownership rather than operating within a highly

layered corporate structure.