Director of Pharmacy Operations and PIC

Valeris is a fully integrated life sciences commercialization partner that provides comprehensive solutions that span the entire healthcare value chain. Formed by the merger of PharmaCord and Mercalis, Valeris™ revolutionizes the path from life sciences innovation to real-life impact to build a world in which every patient gets the care they need. Valeris works on behalf of life sciences companies to improve the patient experience so that patients can access and adhere to critical medications. Backed by proven industry expertise, a deep commitment to patient care, the latest technology, and exceptionally talented team members, Valeris provides the data and strategic insights, patient support services and healthcare provider engagement tools to help life sciences companies successfully commercialize new products. Valeris provides commercialization solutions to more than 500 life sciences customers and has provided access and affordability support to millions of patients. The company is headquartered in Morrisville, North Carolina and Jeffersonville, Indiana. To learn more about Valeris, please visit Position Overview The Director of Pharmacy Operations and PIC is a pivotal leadership role within the pharmacy, with a primary responsibility of overseeing the entire operations of the facility including regulatory and compliance. The Director of Pharmacy Operations and PIC will provide strategic leadership and oversight of clinical pharmacy services, regulatory compliance, quality assurance, and governance functions. This role ensures that all pharmacy services meet the required federal and state laws, industry standards, accreditation requirements, and internal policies. Working closely with pharmacy leadership, the Director will help achieve production goals, support daily operational duties, monitor staff training, and collaborate with education and compliance teams to ensure pharmacy personnel are fully trained and compliant with regulatory requirements. The Director will play a crucial role in fostering a culture of safety, accountability, and patient-centered care, ensuring that high-quality, compliant care is delivered consistently across the organization. This position works collaboratively across all levels of the business – pharmacy operations, shared services, and executive leadership – to support operational success, thereby ensuring the organization's efficiency and continuous improvement. Furthermore, the Director will partner closely with the corporate compliance and quality teams to monitor service quality, identify trends, and implement continuous improvement strategies aimed at enhancing pharmacy performance and patient safety. By overseeing daily operational workflows, monitoring staff training, and ensuring alignment with accreditation standards and internal policies, the Director will contribute to the seamless and compliant operation of the pharmacy. Ultimately, this role is crucial in fostering a culture of safety, integrity, and patient-centered care, while driving operational excellence and ensuring regulatory compliance throughout the organization. You will be working at our specialty mail order pharmacy located in Louisville, KY , part of the Valeris family of companies. We are proud to serve patients with financial need by providing access to essential medications—at no cost to them. All medications are donated directly by manufacturers, allowing us to support patients who would not otherwise have access to treatment. We do not provide bill insurance, making the process simpler for both patients and staff. We are a mail-order only pharmacy—no drive-through services. Our team does not work weekends or holidays. Patients are consistently appreciative of the care and services provided. Key Responsibilities Regulatory & Compliance Oversight 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. Clinical Leadership & Pharmacy Operations 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. Governance, Quality, & Cross-Functional Collaboration 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. Operational Strategy & Workflow Optimization 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. Personnel Management & Development 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. Cross-Functional & External Collaboration 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. Utilize Valeris’ values as the driving force behind the team’s success On time adherence to training deadlines for all corporate policies and procedures Ensure all SOPs are followed with consistency Perform additional tasks or projects as assigned Qualifications 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. Maintain required continuing education (CEU) credits to uphold licensure. Participate in professional development and support staff training initiatives. Perform additional duties as assigned by pharmacy leadership. Ability to lift up to 50 pounds and stand for extended periods. Applicants must complete a criminal background investigation. Independence in clinical discussions and evaluations. Strong interpersonal skills, with the ability to collaborate with cross-functional teams, healthcare providers, and patients. Capable of managing complex situations and providing clear, actionable guidance. Familiarity with computer applications and Windows PC systems, with the ability to learn new, complex computer system applications. Digital dexterity (e.g., proficiency in using a computer keyboard). Physical Demands & Work Environment 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. Prefer candidates who can type at least 35 words per minute with 97% accuracy. Although very minimal, flexibility to travel as needed is preferred. This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, etc. Why Work for Valeris? Medical, dental, and vision plans, including HSA- and FSA-eligible options, with Valeris contributing toward premium costs Additional health support, including telehealth and Employee Assistance Program (EAP) services Company match on Health Savings Account contributions Free Basic Life and AD&D coverage equal to your annual earnings, with a minimum of $50,000 and a maximum of $300,000 Company-paid Short-Term Disability coverage, with the option to purchase Long-Term Disability 401(k) Retirement Savings Plan with 100% match on the first 5% you contribute, with immediate vesting Paid Time Off (PTO) and Sick Leave to support work-life balance Team members receive nine paid holidays plus two floating holidays Opportunities for advancement in a company that supports personal and professional growth A challenging, stimulating work environment that encourages new ideas Work for a company that values diversity and makes deliberate efforts to create an inclusive workplace A mission-driven, inclusive culture where your work makes a meaningful impact Our Commitment to Equal Opportunity At Valeris, we don’t just accept difference – we celebrate it, support it and we thrive on it for the benefit of our employees, our products and our community. Valeris is proud to be an equal opportunity employer. Any offer of employment is contingent upon the successful completion of a background check and, depending on the position, a drug screen in accordance with company standards. Please note that this job description is not intended to be an exhaustive list of all duties, responsibilities, or activities associated with the position. Responsibilities and tasks may be modified at any time, with or without notice. #J-18808-Ljbffr SupportFinity™