Director of Pharmacy Operations

Revelation Pharma LLC

10d•Remote

About The Position

The Director of Pharmacy Operations — 503b 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 503b outsourcing 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 outsourcing capabilities, develop existing infrastructure, and position each facility for sustainable production scale. This position’s primary mandate is to drive 503b outsourcing performance and maximize the impact of Revelation Pharma’s 503b network. Depending on organizational need, this role may also carry oversight or advisory responsibility for select 503a facilities — particularly as it relates to network integration and capacity planning. In all cases, the strategic focus and performance accountability of this role remain anchored in 503b operations and their contribution to the Revelation Pharma network.

Requirements

PharmD or Bachelor's degree in Pharmacy required.
Minimum 4 years of direct 503b outsourcing pharmacy experience required, with demonstrated involvement in production operations, regulatory compliance, and/or facility management.
Direct experience with FDA inspections, cGMP compliance programs, and 21 CFR Parts 210/211 is required.
Demonstrated track record of leading facility development projects, capacity expansion, or production scaling initiatives.
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.

Nice To Haves

Proven leadership experience in a multi-site or high-volume compounding/pharmaceutical manufacturing environment strongly preferred.
Experience with lean manufacturing, Six Sigma, or continuous improvement methodologies is highly desirable.

Responsibilities

Lead the strategic assessment and buildout of existing 503b outsourcing 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 (IQ/OQ/PQ), 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 outsourcing 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 FDA inspections across all 503b registered outsourcing facilities, ensuring site systems, documentation, and personnel practices meet or exceed 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.
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 outsourcing pharmacy, including automation, ERP/MES system enhancements, and evolving compounding technologies; collaborate with IT nationally and locally as needed.
Conduct structured assessments of Revelation Pharma’s 503a compounding facilities to identify capacity constraints, formulary gaps, and service limitations that represent opportunities for 503b augmentation.
Develop and maintain a network-wide view of 503a demand patterns, identifying high-volume or complex formulations where 503b outsourcing can deliver superior consistency, scalability, and regulatory reliability.
Collaborate with 503a site leadership and Sales teams to design referral and supply pathways that allow 503b facilities to supplement or expand upon 503a offerings — reducing 503a production burden while elevating the overall quality and breadth of Revelation’s compounding portfolio.
Identify specific therapeutic categories or dosage forms where 503b production capabilities (e.g., sterile injectables, controlled environment fill/finish) can address unmet needs within the 503a network and build a pipeline of products accordingly.
Evaluate capacity headroom at 503b facilities relative to current and projected 503a referral volume; develop capacity planning models that optimize utilization across the full Revelation Pharma network.
Partner with Regulatory Affairs to ensure that any 503b products introduced to augment 503a offerings are compliant with applicable federal and state requirements, and that site-of-dispensing workflows are clearly defined and documented.
Present network integration findings, opportunity assessments, and 503b augmentation roadmaps to senior leadership on a regular cadence to support enterprise-level strategic planning.
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.