PIC - Sterile Compounding (Nashville, TN)

Unitas; Nashville (TN); On-site; USD 168,000 - 206,000; Full time

Benefits offered by this job

PTO 15 days

Paid holidays

Job summary

UNITAS is seeking a Pharmacist-in-Charge to provide executive leadership, clinical oversight, and regulatory compliance for a state-licensed 503A sterile compounding pharmacy. You will ensure adherence to USP standards, laws, and policies while guiding operations and staff. The role demands strongest leadership, integrity, and a commitment to patient safety. Monday–Friday expectations may apply.

Qualifications

• Pharm.D. degree from an accredited school.
• Current, active pharmacist license in the state where the pharmacy is located.
• Meets all state requirements to serve as the Pharmacist-in-Charge of a 503A compounding pharmacy.
• Experience with sterile compounding and USP standards.
• Strong leadership and problem-solving skills.
• Proficiency with pharmacy management systems and electronic documentation.

Responsibilities

• Serve as Pharmacist-in-Charge under state law and Board of Pharmacy regulations.
• Ensure compliance with 503A, FDA requirements, and USP standards.
• Oversee daily sterile compounding operations and documentation.
• Lead quality assurance, environmental monitoring, and CAPA programs.
• Manage staff training, competency assessments, and supervision.
• Maintain licenses, registrations, and regulatory records.
• Coordinate inspections and respond to regulatory inquiries.

Skills

Leadership

Pharmacy law

Sterile compounding

Education

Pharm.D.

Tools

Pharmacy management systems

Job description

UNITAS provides clinical staffing and consulting solutions, including contract staff augmentation, permanent talent recruiting, consulting, and clinical coaching. Our extensive experience includes Pharmacy Benefit Management, Long-Term Care, Retail Pharmacy, Hospital, and Leadership, enabling us to connect the best clinical talent with outstanding companies. We know clinicians because we are clinicians!

About the Role

The Pharmacist-in-Charge (PIC) provides overall professional, clinical, operational, and regulatory oversight of a state-licensed 503A compounding pharmacy specializing in sterile preparations. Reporting to the pharmacy owners, the PIC ensures that all pharmacy activities comply with applicable federal and state laws, Board of Pharmacy regulations, United States Pharmacopeia (USP) standards, and established pharmacy policies and procedures. The PIC leads sterile compounding operations, personnel competency, quality assurance, environmental monitoring, documentation, medication safety, and continuous quality improvement—maintaining a culture of safety, compliance, accuracy, and operational excellence while ensuring that compounded preparations meet established standards for quality, strength, purity, and intended use.

What You'll Do

Regulatory Compliance & Pharmacy Oversight

• Serve as the Pharmacist-in-Charge and fulfill all associated responsibilities under applicable state law and Board of Pharmacy regulations
• Maintain compliance with Section 503A of the Federal Food, Drug, and Cosmetic Act, relevant FDA requirements, and applicable state and federal pharmacy laws
• Ensure compliance with applicable USP standards, including USP <797> (sterile preparations), <795> where applicable, and <800> for hazardous drugs
• Maintain current pharmacy licenses, permits, registrations, policies, procedures, and required records
• Oversee pharmacy inspections, regulatory inquiries, and corrective action plans, and respond to regulatory findings
• Maintain policies and procedures for prescription intake, compounding authorization, dispensing, labeling, storage, distribution, recalls, and record retention, and ensure activities meet 503A patient-specific requirements
• Monitor regulatory changes and implement appropriate updates to pharmacy practices and procedures
• Oversee daily sterile compounding operations for compliance with approved formulations, master formulation and compounding records, and established procedures
• Ensure appropriate controls for personnel garbing, hand hygiene, aseptic technique, cleaning, disinfection, and material transfer
• Oversee environmental monitoring programs, including viable and nonviable air sampling and surface sampling
• Ensure qualification, certification, and maintenance of cleanrooms, primary engineering controls, and other critical equipment
• Establish and maintain procedures for beyond-use dating (BUD), storage, transport, and handling of compounded sterile preparations
• Ensure appropriate ingredient sourcing, supplier qualification, component inspection, and verification of ingredient identity and quality
• Review and approve compounding procedures, formulations, and documentation, and ensure preparations are compounded, inspected, labeled, and released only by trained, authorized personnel
• Investigate deviations, contamination events, and sterility concerns, and implement corrective and preventive actions

Quality Assurance & Quality Control

• Develop, implement, and maintain a comprehensive quality assurance program for sterile compounding operations
• Establish procedures for quality control, documentation review, product release, and investigation of discrepancies
• Ensure appropriate testing (e.g., sterility, bacterial endotoxins, potency) when required by applicable standards, product characteristics, or procedures
• Review environmental monitoring results, equipment performance, personnel competency records, and quality indicators; identify trends and assess risks
• Maintain procedures for complaints, adverse events, product defects, recalls, and potential patient safety concerns, and implement corrective and preventive actions (CAPA)
• Ensure complete, accurate, and retrievable records, and lead continuous improvement initiatives to reduce errors and strengthen patient safety
• Supervise and provide professional direction to pharmacists, pharmacy technicians, and other personnel involved in pharmacy operations
• Establish training, qualification, and competency assessment programs for sterile compounding personnel
• Ensure initial and ongoing competency assessments are completed at required intervals and documented appropriately
• Verify that personnel meet applicable licensing, registration, training, and qualification requirements
• Oversee competency in aseptic technique, garbing, cleaning, disinfection, and hazardous drug handling where applicable
• Promote accountability, professionalism, and teamwork, and address performance concerns and noncompliance in a timely, documented manner

Clinical & Medication Safety

• Provide pharmacist oversight of prescription review, ingredient selection, formulation appropriateness, calculations, labeling, and final verification
• Assess prescription completeness, patient‑specific needs, dosage, route of administration, and potential incompatibility or safety concerns
• Support communication with prescribers and other healthcare professionals regarding compounded preparations
• Establish processes for identifying, documenting, and addressing medication errors, adverse events, and product complaints
• Protect patient confidentiality and maintain compliance with applicable privacy requirements
• Oversee qualification, calibration, maintenance, cleaning, and performance monitoring of equipment used in compounding and quality assurance
• Ensure cleanrooms, controlled environments, refrigerators, freezers, and storage areas are maintained within established specifications, and review temperature monitoring and excursion investigations
• Ensure inventory controls, expiration‑date monitoring, storage conditions, and traceability of active pharmaceutical ingredients and components
• Maintain procedures for receiving, quarantine, release, rejection, and disposal of materials, and coordinate facility maintenance, certification, and remediation

Documentation & Administration

• Develop, review, approve, and maintain pharmacy policies, standard operating procedures (SOPs), and training materials
• Ensure timely, accurate completion of compounding, prescription, personnel, equipment, cleaning, and quality records
• Provide reports on pharmacy performance, compliance status, quality trends, and operational risks to ownership
• Participate in budgeting, staffing, workflow planning, and operational improvement initiatives
• Maintain appropriate communication with regulatory authorities, healthcare professionals, vendors, and other stakeholders
• Other duties as assigned.

Qualifications

Minimum Qualifications

• Education: Graduate of an accredited School or College of Pharmacy with a Doctor of Pharmacy (Pharm.D.) or other qualifying pharmacy degree
• Licensure: Current, active pharmacist license in the state where the pharmacy is located, in good standing and without restrictions that would prevent performance of the role
• PIC Eligibility: Meets all applicable state requirements to serve as the Pharmacist-in-Charge of a 503A compounding pharmacy
• Sterile Compounding: Demonstrated experience in sterile compounding and knowledge of applicable USP standards and regulatory requirements
• Technical Knowledge: Knowledge of aseptic technique, cleanroom operations, environmental monitoring, personnel competency assessment, quality assurance, and contamination control
• Pharmacy Law & Quality: Strong understanding of pharmacy law, medication safety, documentation requirements, and compounding quality systems
• Regulatory Judgment: Ability to interpret regulations, develop policies and procedures, investigate deviations, and implement effective corrective actions
• Leadership: Strong leadership, communication, organizational, and problem‑solving skills
• Systems: Proficiency with pharmacy management systems, electronic documentation, and standard business software

Preferred Qualifications

• Two or more years of experience in sterile compounding pharmacy operations or a comparable pharmacy leadership role
• Previous experience serving as a Pharmacist-in-Charge, pharmacy manager, or sterile compounding supervisor
• Experience preparing for and responding to Board of Pharmacy inspections or other regulatory audits
• Experience managing USP compliance programs, environmental monitoring, cleanroom certification, and quality assurance initiatives
• Relevant sterile compounding training, certifications, or documented advanced competency
• Schedule: Monday through Friday (specific daily hours to be determined)
• Compensation: Estimated $187,200 per year
• Paid Time Off: 15 days of PTO to start
• Paid Holidays: New Year’s Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, and Christmas Day