Mercalis · 3 hours ago
Director of Pharmacy Operations and Pharmacist in Charge
Louisville, KY
Full-time
Onsite
Lead/Staff, Director/Executive
5+ years expMercalis is seeking an experienced Director of Pharmacy Operations and Pharmacist-in-Charge to lead their specialty mail-order pharmacy in Louisville, KY. This role involves providing strategic and operational leadership for clinical services, regulatory compliance, quality assurance, and staff development.
Clinical TrialsHealth CareManufacturingMarketingPharmaceutical
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
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. 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)
Preferred
Additional state pharmacist licenses
Company
Mercalis
Mercalis is an integrated life sciences commercialization that offers comprehensive solutions across the healthcare value chain.
501-1000 employees
H1B Sponsorship
Mercalis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2025-03-12Acquired
2011-05-18Series Unknown
Leadership Team
Scott Dulitz
Chief Executive Officer
Recent News
2025-07-04
2025-05-10
Company data provided by crunchbase