Director of Pharmacy Operations – 503A

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TeleHealth

WebsiteLinkedInAll Job Openings

2 - 10 employees

Founded 2016

🏥 Healthcare

Healthcare

TeleHealth is a healthcare company (LinkedIn lists it under Hospitals and Health Care). TeleHealth offers telemedicine and virtual care services and/or platforms that enable remote patient–clinician interactions, remote consultations, and other digital health services.

📋 Description

• 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