Director of Pharmacy Operations (503A)

JOB DESCRIPTION

Director of Pharmacy Operations

503a Compounding Pharmacies • Facility Development & Production Scaling

ROLE SUMMARY

The Director of Pharmacy Operations 503a is a senior strategic leader who works in close partnership with local facility leadership to drive performance, regulatory excellence, and long-term growth across our 503a compounding pharmacy portfolio. Rather than managing day-to-day operations directly, this role functions as an enabler and architect — establishing the frameworks, standards, and development roadmaps that empower facility GMs and production managers to execute with confidence. Reporting to the VP of Operations, this leader collaborates cross-functionally with Quality, Regulatory Affairs, Marketing, and Sales teams to advance compounding capabilities, develop existing infrastructure, and position each facility for sustainable production scale.

RESPONSIBILITIES

503a Facility Development & Production Scaling

• 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 (e.g., 5S, Kaizen, Six Sigma) 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.

503a Regulatory Compliance & Quality Oversight

• 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 — reinforcing that compliance and scale are mutually achievable — 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.

Compounding Operations & Service Excellence

• Partner with facility GMs and production managers to align on operational priorities, performance expectations, and service standards — providing strategic direction and removing barriers rather than managing day-to-day execution directly.
• Collaborate with local leadership to co-develop service and quality plans for each facility, with particular focus on order fulfillment accuracy, product sterility and potency, and on-time delivery to health system customers — supporting facility teams in owning and executing against those plans.
• Collaborate with Commercial and Customer Success teams to align production scheduling with customer demand, manage supply commitments, and proactively communicate capacity constraints or changes.
• Ensure departments keep pace with technical innovation in compounding pharmacy, including automation, QMS system enhancements, and evolving compounding technologies; collaborate with IT nationally and locally as needed.

Financial Performance

• Own the operational P&L for assigned 503a facilities, driving EBITDA growth through a disciplined focus on cost of goods, labor efficiency, waste reduction, and revenue capture optimization.
• Lead budget development and resource planning for all facilities, including capital expenditure requests tied to facility development and scaling initiatives.
• Identify and implement cost-reduction opportunities across raw material procurement, batch production scheduling, and operational overhead without compromising quality or compliance.
• Ensure accurate revenue capture, billing integrity, and timely cash collection in coordination with Finance and Revenue Cycle teams.

People Leadership & Organizational Development

• Work in partnership with facility GMs to assess and strengthen the leadership team at each site, helping identify gaps in the bench of production managers, QA leads, and operations supervisors and supporting plans to address them.
• Serve as a trusted advisor and coach to facility GMs, offering guidance on operational leadership challenges, regulatory navigation, business acumen, and workforce development — helping local leaders grow their capabilities rather than supplanting their decision-making.
• Support facility GMs in conducting meaningful performance and development conversations with their teams; engage directly with GM-level talent on individual growth, succession planning, and retention in coordination with HR.
• Conduct periodic on-site visits to each facility to engage with local leadership, observe operations firsthand, surface systemic challenges, and reinforce organizational standards — visiting as a strategic partner, not an auditor.
• Collaborate with facility GMs to ensure site-level training programs, onboarding frameworks, and competency assessments are in place and aligned with cGMP requirements — supporting local ownership of staff development rather than managing it centrally.

QUALIFICATIONS & EDUCATION 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.

KEY PERFORMANCE METRICS

REQUIRED TOOLS & RESOURCES 

• Laptop and mobile device
• Travel budget (up to 25% travel to facility locations)
• Access to ERP/MES, QMS, and operational reporting platforms

Benefits

• Health care insurance (medical, dental, vision)
• Life Insurance
• Supplemental Insurance 
• PTO
• 401K matching
• Sick leave

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Revelation Pharma is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.