Director of Pharmacy Operations – 503A

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the strategic evaluation and enhancement of current 503a compounding facilities by identifying deficiencies in infrastructure, equipment, cleanroom capacity, and workflows that impede production efficiency.

• Develop and implement a phased facility development strategy that aligns with commercial demand projections, incorporating capital project planning, equipment qualification, and process validation milestones.

• Drive initiatives to scale production by assessing existing batch sizes, fill/finish capacities, formulation pipelines, and staffing models to boost output without sacrificing product quality or compliance.

• Oversee the adoption of lean manufacturing principles and continuous improvement practices to eliminate bottlenecks and enhance production efficiency across all facilities.

• Collaborate with Engineering and Facilities teams on cleanroom upgrades, HVAC qualifications, water system improvements, and other infrastructure investments necessary to support increased compounding operations.

• Define and track production KPIs such as batch yield, cycle time, on-time release rates, and capacity utilization; leverage data to inform operational decisions and report progress to senior leadership.

• Ensure operational readiness for inspections by the state Board of Pharmacy and FDA across all 503a compounding facilities, ensuring that site systems, documentation, and personnel practices comply with or exceed USP and applicable cGMP standards.

• Provide direction and oversight regarding state Board of Pharmacy licensure, DEA registration, and federal statutory requirements relevant to each facility location.

• Collaborate closely with Quality Assurance and Regulatory Affairs teams to ensure that SOPs, batch records, environmental monitoring programs, and deviation management systems are up-to-date, compliant, and effectively implemented.

• Promote a quality-driven culture across all facilities through visible leadership, investment in training, and robust accountability frameworks.

• Lead the operational response to FDA Form 483 observations, warning letters, or significant quality incidents, including conducting root cause analysis, developing CAPA plans, and verifying effectiveness.

⛳️ Requirements

• PharmD or Bachelor's degree in Pharmacy is required.

• At least 4 years of direct experience in 503a compounding pharmacy is required, showcasing involvement in production operations, regulatory compliance, and/or facility management.

• Experience in a 503b outsourcing facility is highly advantageous.

• Strongly preferred is proven leadership experience in a multi-site or high-volume compounding/pharmaceutical manufacturing setting.

• Required is direct experience with state Board of Pharmacy oversight, USP sterile and non-sterile compounding standards, and cGMP compliance programs; familiarity with FDA inspections is an advantage.

• A demonstrated history of leading facility development projects, capacity expansions, or production scaling initiatives is essential.

• Experience with lean manufacturing, Six Sigma, or continuous improvement methodologies is highly desirable.

• Strong financial acumen with experience in managing operational budgets, capital projects, and P&L accountability.

• Exceptional communication skills and executive presence, capable of credibly representing operations to regulators, health system customers, and senior leadership.

🏝️ Benefits

• Health care insurance (medical, dental, vision)

• Life Insurance

• Supplemental Insurance

• PTO

• 401K matching

• Sick leave