Coordinator- Pharmacy Operations & Regulatory Affairs

Overview

 

 

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POSITION SUMMARY

The Coordinator, Pharmacy Operations & Regulatory Affairs is a pharmacist leader responsible for building and sustaining a high-reliability operating model for our Lakeland pharmacy. This role partners closely with the Director of Pharmacy, fulfillment leaders, Quality, Compliance, and Technology to strengthen operational governance, SOPs, accreditation readiness, controlled substance program safeguards, and new program launch execution.

 

This position is designed for an execution-oriented leader who can translate “what good looks like” into practical workflows, documentation, training, and measurable outcomes—while driving cross-functional projects that continuously improve quality, compliance, productivity, and scalability.

 

Onsite - KEP / Hybrid per Business Needs

Responsibilities

KEY RESPONSIBILITIES:

 

1) Operational Optimization & Best Practices

• Own and maintain the site-level Operating Standards for pharmacy practice and fulfillment execution (e.g., floor practices, controls, handoffs, error mitigation).
• Lead structured problem-solving for operational friction points (root cause, corrective action, prevention plans), partnering with fulfillment leadership to ensure adoption.
• Partner with Quality and Investigation/Reporting teams to define, monitor, and interpret key indicators of quality, compliance, and inspection readiness (e.g., SOP adherence, deviations, audit findings, CAPA timeliness/aging, training completion), ensuring trends and insights are communicated to site leadership for action.
• Drive productivity improvements and maintain a KPI cadence for throughput, labor efficiency, cycle time, and backlog/aging; translate performance gaps into actionable improvement plans.
• Support Client Services by providing timely operational information and fulfillment metrics (e.g., SLAs, turnaround times, backlog status, error/rework drivers), and by partnering with Operations/Quality to investigate and help resolve client concerns related to fulfillment performance and patient experience.

 

2) SOP Governance, Documentation & Training

• Build and manage the SOP lifecycle: authoring, initial review, implementation, and periodic review.
• Ensure SOPs are operationally “usable” (clear roles/responsibilities, stepwise procedures, forms/templates, escalation pathways).
• Coordinate training content and rollout for new/updated SOPs; validate competency where needed (pharmacists, technicians, support teams).

 

3) Quality, Accreditation & Inspection Readiness

• Serve as a primary site SME for accreditation maintenance and readiness (e.g., NABP/URAC/ACHC as applicable), including evidence management and audit response coordination.
• Partner with Quality to manage deviations, investigations, CAPAs, change control, and internal audit schedules.
• Maintain a constant state of inspection readiness: mock BOP inspections, walkthroughs, documentation hygiene, and readiness “drills.”

 

4) Controlled Substance Program Development & Management

• Partner with Compliance leadership to design and operationalize, and maintain controlled substance workflows (receiving, storage, perpetual inventory, dispensing controls, reconciliation, discrepancy management, reporting, and monitoring).
• Draft/maintain SOPs, logs, and training associated with controlled substance handling; support readiness for DEA/BOP expectations.
• Support controlled substance program scaling (new products, new workflows, increased volume) with disciplined change control and validation.

 

5) Program Buildout & Launch Support (Including White-Label / Client Programs)

• Act as the site project resource for operational readiness for new programs: requirements translation, process mapping, SOPs, training, go-live checklists, and stabilization monitoring.
• Coordinate across Operations, Client/Program teams, Quality, Compliance, and Technology to ensure launches meet safety, compliance, and service expectations.
• Support white-label pharmacy models by ensuring consistent core practices while accommodating program-specific requirements in a controlled, documented way.

 

6) PMS, Automation, & Workflow Validation<