Director of Pharmacy Operations – 503A
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Job Description
Director of Pharmacy Operations overseeing 503a compounding pharmacy facilities and collaborating with cross-functional teams to drive quality and regulatory compliance across the network.
Responsibilities:
- Lead the strategic assessment and buildout of existing 503a compounding facilities, identifying gaps in infrastructure, equipment, cleanroom capacity, and workflow that limit production throughput.
- Develop and execute a multi-phase facility development roadmap aligned with commercial demand forecasts, including capital project planning, equipment qualification, and process validation milestones.
- Drive production scaling initiatives by evaluating current batch sizes, fill/finish capacity, formulation pipelines, and staffing models to increase output without compromising product quality or compliance.
- Oversee the implementation of lean manufacturing and continuous improvement methodologies to eliminate bottlenecks and improve production efficiency across all facilities.
- Partner with Engineering and Facilities teams on cleanroom upgrades, HVAC qualification, water system enhancements, and other infrastructure investments required to support higher-volume compounding operations.
- Define and monitor production KPIs including batch yield, cycle time, on-time release rates, and capacity utilization; use data to drive operational decisions and report progress to the senior leadership team.
- Maintain operational readiness for state Board of Pharmacy and FDA inspections across all 503a compounding facilities, ensuring site systems, documentation, and personnel practices meet or exceed USP <795>/<797> and applicable cGMP requirements.
- Provide guidance and oversight on state Board of Pharmacy licensure, DEA registration, and federal statutory requirements applicable to each facility location.
- Partner closely with the Quality Assurance and Regulatory Affairs functions to ensure SOPs, batch records, environmental monitoring programs, and deviation management systems are current, compliant, and effectively executed.
- Champion a quality culture across all facilities through visible leadership, training investment, and accountability structures.
- Lead operational response to FDA Form 483 observations, warning letters, or significant quality events, including root cause analysis, CAPA development, and effectiveness of verification.
Requirements:
- PharmD or Bachelor's degree in Pharmacy required.
- Minimum 4 years of direct 503a compounding pharmacy experience required, with demonstrated involvement in production operations, regulatory compliance, and/or facility management.
- Experience in a 503b outsourcing facility is a strong advantage.
- Proven leadership experience in a multi-site or high-volume compounding/pharmaceutical manufacturing environment strongly preferred.
- Direct experience with state Board of Pharmacy oversight, USP <795>/<797> sterile and non-sterile compounding standards, and cGMP compliance programs is required; familiarity with FDA inspections is an advantage.
- Demonstrated track record of leading facility development projects, capacity expansion, or production scaling initiatives.
- Experience with lean manufacturing, Six Sigma, or continuous improvement methodologies is highly desirable.
- Strong financial acumen with experience managing operational budgets, capital projects, and P&L accountability.
- Exceptional communication and executive presence; ability to represent operations credibly to regulators, health system customers, and senior leadership.
Benefits:
- Health care insurance (medical, dental, vision)
- Life Insurance
- Supplemental Insurance
- PTO
- 401K matching
- Sick leave
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