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Valeris · 20 hours ago

Director of Pharmacy Operations

Louisville Metro

Full-time

Onsite

Lead/Staff, Director/Executive

5+ years exp

Valeris is a fully integrated life sciences commercialization partner that provides comprehensive solutions that span the entire healthcare value chain. The Director of Pharmacy Operations and PIC is responsible for overseeing the entire operations of the pharmacy, ensuring compliance with regulatory standards, and providing strategic leadership for clinical pharmacy services.

ConsultingLife SciencePharmaceutical

Hiring Manager

Shannon Justus

Responsibilities

Serve as the Pharmacist-in-Charge (PIC) for the licensed facility, ensuring compliance with all federal and state pharmacy rules, regulations, and laws

Maintain PIC responsibilities across various state jurisdictions, ensuring compliance for facility licensure

Monitor and interpret pharmacy laws, regulations, and guidance from governing bodies such as State Boards of Pharmacy, DEA, FDA, CMS, and other entities

Lead regulatory audits, including facility license renewals, change of ownership filings, and other licensing initiatives

Develop, implement, and maintain policies and procedures to ensure compliance with REMS, DSCSA, HIPAA, URAC, and internal company standards

Investigate and resolve compliance issues, quality-related medication incidents, and deviations using CAPA (Corrective and Preventive Action) processes

Maintain strict confidentiality of patient health information in compliance with HIPAA standards

Oversee clinical services, including drug reviews and patient safety initiatives, to ensure safe and effective medication use

Collaborate with prescribers, manufacturer clients, and other healthcare providers to resolve clinical escalations and enhance therapy outcomes and patient experiences

Evaluate and implement technological and workflow improvements to optimize prescription processing, documentation, and patient safety

Oversee prescription accuracy and ensure safe medication use throughout the pharmacy workflow

Oversee prescriptions for clinical accuracy, contraindications, and drug interactions during the order verification process

Collaborate to promote a just culture, regulatory transparency, and continuous quality improvement

Collaborate with pharmacy operations, compliance and quality teams, corporate leadership, and shared services to align pharmacy performance with organizational goals

Partner with the corporate quality team to track and analyze performance data, monitor patient safety events, and implement corrective actions to enhance service quality

Represent the pharmacy in communications with regulatory bodies, REMS administrators, accreditation bodies, and manufacturer clients

Lead and support initiatives for the pharmacy’s quality management and continuous quality assurance programs

Evaluate and implement workflow and technological improvements to enhance operational efficiency and patient care

With operations, monitor key performance indicators (KPIs), production goals, and staff performance metrics to improve operational performance or enhance workflow processes and training initiatives

Use performance metrics to guide staffing decisions, identify process delays, and improve documentation standards

Ensure accurate and complete documentation of services rendered, products delivered, and patient education

Supervise and enforce workflow standards, ensuring pharmacist oversight and operational consistency

Oversee pharmacy opening and closing procedures, either directly or through delegation to staff

Manage onboarding, training, continuing education, and competency assessments for pharmacy personnel

Provide coaching, conduct performance reviews, and hold staff accountable to meet productivity and compliance goals

Promote interdepartmental education for pharmacy personnel, healthcare providers, and patients

Represent the pharmacy for client audits and quarterly business reviews. Present during capabilities presentations and support in client pitches

Serve as the pharmacy’s regulatory representative in interactions with boards of pharmacy, manufacturer clients, auditors, and other accreditation bodies

Partner with corporate teams to implement and monitor compliance reporting tools, such as LicenseComply, RegComply, and QuREy

Coordinate with legal, compliance, operations, and shared services teams to ensure cross-functional alignment

Qualification

Pharmacist-in-ChargeRegulatory complianceClinical pharmacy servicesPharmacy management systemsPharmacy laws knowledgeAnalytical skillsInterpersonal skillsCommunication skills

Required

Doctor of Pharmacy (PharmD) from an accredited school of pharmacy

Active and unrestricted pharmacist license in good standing in Kentucky with the ability to obtain licensure in additional states as required for business needs

Active and unrestricted non-resident state licenses as required by boards of pharmacies to dispense in those states as a mail order pharmacy strongly preferred. States include Alabama, Arkansas, Kansas, Louisiana, Maryland, Michigan, Mississippi, Nebraska, Oklahoma, Oregon, Tennessee, Texas, Virginia and West Virginia. Iowa, Idaho and Pennsylvania

Minimum of 5–8 years of experience in clinical pharmacy, regulatory compliance, or specialty/mail-order pharmacy operations

Proven experience as a Pharmacist-in-Charge or in a similar regulatory leadership role

Minimum of 2–5 years of management experience, overseeing no fewer than 3 direct/indirect reports

Previous experience working with auditors, inspectors, and regulatory agencies

Strong knowledge of pharmacy laws, including REMS, DSCSA, HIPAA, state-specific Board of Pharmacy regulations, and URAC standards

Experience interpreting compliance requirements and regulations from the DEA, FDA, and state pharmacy boards

Proficiency with pharmacy management systems and regulatory databases

Familiarity with customer relationship management systems

Strong analytical, interpersonal, and communication skills, with the ability to effectively manage cross-functional teams and stakeholders

Ability to use pharmaceutical and medical reference literature to provide drug information to healthcare providers and patients

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit for long periods of time, use hands to type, handle or feel; and reach with hands and arms. Must be able to type 35 WPM with 97% accuracy