VP of 503B Services in at Revelation Pharma LLC
Explore Related Opportunities
Job Description
ROLE SUMMARY
The Vice President of 503B Services is the enterprise leader responsible for building, scaling, and optimizing Revelation Pharma’s 503B outsourcing facility network. This is a greenfield and expansion role — the VP owns the full lifecycle from site identification and real estate evaluation through facility design, construction oversight, technology implementation, and ongoing production scaling across multiple locations.
Reporting directly to the COO, this executive defines the capital strategy and operational architecture that will position Revelation Pharma as a dominant multi-site 503B operator nationwide. The VP is the integrating force between Regulatory Affairs, Quality Assurance, Engineering, and Commercial — accountable for converting strategic intent into built, licensed, and producing 503B facilities.
Note on Scope: This position carries full capital and operational accountability for the 503B network — including site development from greenfield evaluation through production ramp, automation strategy, multi-site leadership, and network-level P&L performance. The VP sets the long-range infrastructure roadmap and represents 503B operations at the executive level. |
RESPONSIBILITIES
Site Identification & Facility Development
- Lead real estate evaluation and site selection for new 503B outsourcing facilities, assessing market access, regulatory environment, workforce availability, logistics infrastructure, and build-out feasibility for USP 797/800-compliant cleanroom operations.
- Develop and own the facility development playbook: site criteria matrix, lease/build/acquire decision frameworks, construction partner RFP and selection, and project governance standards to be applied consistently across all network expansion initiatives.
- Manage the full capital project lifecycle from architectural programming and design review through construction oversight, commissioning, IQ/OQ/PQ validation, and FDA outsourcing facility registration — delivering projects on time and on budget.
- Partner with Regulatory Affairs to navigate state Board of Pharmacy licensure, DEA registration, and federal 503B registration requirements for each new site, ensuring no production delays attributable to licensure gaps.
- Build business cases and capital expenditure requests for each development project, including ROI modeling, capacity utilization projections, and risk-adjusted timelines for presentation to the COO and Board.
Automation & Technology Implementation
- Define and execute the network automation strategy for compounding operations, identifying, evaluating, and implementing robotic dispensing, automated filling and finish systems, MES/ERP integration, and environmental monitoring platforms across facilities.
- Lead vendor selection and contract negotiation for automation capital equipment; manage installation qualification, operator training, and change control in compliance with cGMP and 21 CFR Parts 210/211.
- Establish technology standards and an approved-vendor list for compounding automation across the network, ensuring consistency, maintainability, and scalability as new sites come online.
- Continuously evaluate emerging automation and compounding technologies — including robotics, closed-system transfer, gravimetric filling, and AI-assisted QC inspection — to maintain competitive production capability and drive cost-per-unit reduction.
- Collaborate with IT and QA to ensure automation systems are validated, audit-ready, and integrated into batch record and deviation management workflows.
503B Regulatory Compliance & Quality Oversight
- Maintain FDA inspection readiness across all 503B outsourcing facilities, ensuring CGMP systems, documentation, and personnel practices meet or exceed 21 CFR Parts 210/211 and applicable USP chapter requirements.
- Serve as the executive owner of FDA Form 483 responses, warning letter remediation, and CAPA programs at the network level — directly engaging FDA when escalation is required.
- Partner with VP of Quality Assurance to ensure SOPs, batch records, environmental monitoring programs, and deviation management systems are current, compliant, and effectively executed at every site.
- Champion a quality-first culture across all 503B operations, reinforcing that compliance and scale are mutually achievable through visible leadership, resource investment, and accountability structures.
Multi-Site Operations & Production Scaling
- Own the network-level production P&L for all 503B facilities, driving EBITDA performance through disciplined management of COGS, labor efficiency, automation-enabled throughput gains, and waste reduction.
- Lead production scaling initiatives across sites: evaluating batch sizes, fill/finish capacity, formulation pipeline alignment, and staffing models to increase output without quality or compliance compromise.
- Develop and monitor production KPIs including batch yield, cycle time, on-time release rates, capacity utilization, and cost-per-unit; use performance data to drive decisions and surface emerging risks to executive leadership.
- Oversee lean manufacturing and continuous improvement programs (5S, Kaizen, Six Sigma) across all facilities to eliminate bottlenecks and sustain operational discipline at scale.
- Collaborate with Commercial and Customer Success to align production scheduling with customer demand, manage supply commitments, and proactively communicate capacity constraints or changes.
Mergers & Acquisitions — Subject Matter Expert
- Serve as the primary operational SME for 503B-related M&A activity, partnering with executive leadership, investment advisors, and legal counsel to evaluate acquisition targets within the compounding and outsourcing pharmacy space.
- Lead operational due diligence on acquisition candidates: assessing facility condition, cleanroom compliance status, production capability, equipment quality, regulatory history (FDA inspection records, 483s, warning letters), workforce, and integration complexity.
- Develop and own the post-acquisition integration playbook for 503B assets — covering facility standardization, system migration (ERP/MES/QMS), SOP alignment, licensure transitions, and production ramp under Revelation Pharma’s quality framework.
- Provide acquisition valuation input from an operational lens: quantifying CapEx required to bring a target to network standards, estimating time-to-production contribution, and identifying operational risks that should influence deal structure or pricing.
- Lead the operational integration of acquired 503B facilities into the Revelation network, serving as the accountable executive from deal close through stabilized production — with clear milestones, escalation paths, and reporting to the COO.
- Maintain current intelligence on potential acquisition targets in the 503B space, including closed or distressed facilities, licensure databases, and market participants — proactively surfacing opportunities that align with Revelation Pharma’s network buildout strategy.
People Leadership & Organizational Development
- Build and lead a high-performing 503B operations organization, including direct leadership of the Director of 503B Operations, Site General Managers, and project/engineering functions — with accountability for org design, succession, and talent pipeline at every level.
- Develop leaders, not just managers: establish performance expectations, individual development plans, and coaching cadences that grow the next tier of 503B operational leadership within Revelation Pharma.
- Conduct regular site visits to engage with local teams, observe operations firsthand, identify systemic challenges, and reinforce organizational standards — present as a strategic partner and culture carrier, not an auditor.
- Partner with HR on compensation benchmarking, retention strategy, and leadership succession planning for all 503B operations roles.
Other duties as assigned.
QUALIFICATIONS & EDUCATION REQUIREMENTS
- PharmD, Bachelor’s degree in Pharmacy, or B.S./M.S. in Engineering required; MBA or equivalent business training strongly preferred.
- Minimum 10 years of progressive leadership experience in 503B outsourcing pharmacy, pharmaceutical manufacturing, or high-volume sterile compounding — with demonstrated multi-site accountability.
- Proven track record of building or scaling 503B outsourcing operations across more than one location, including direct experience owning facility development from site selection through regulatory registration and production launch.
- Direct experience overseeing construction, cleanroom design, and commissioning of USP 797/800-compliant facilities, including IQ/OQ/PQ and FDA outsourcing facility registration.
- Demonstrated experience identifying, selecting, and implementing automation in compounding or pharmaceutical manufacturing environments — robotic dispensing, automated filling, MES/ERP integration, or equivalent.
- Direct experience with FDA inspections, cGMP compliance programs, 21 CFR Parts 210/211, and USP chapters 795/797/800 is required.
- Strong capital project management skills: business case development, CapEx management, contractor oversight, and on-time/on-budget delivery.
- Proven people leader with experience developing multi-level teams and building leadership bench strength in complex, regulated environments.
- Experience supporting or leading M&A activity in a pharmaceutical, compounding, or healthcare services context — including operational due diligence and post-acquisition integration — is strongly preferred.
- Strong financial acumen with experience owning operational P&L, managing capital budgets, and driving EBITDA performance.
- Exceptional executive presence; ability to represent 503B operations credibly to regulators, health system customers, investors, and the Board.
KEY PERFORMANCE METRICS
Metric | Description |
EBITDA | Network-level and site-level EBITDA performance vs. budget |
Site Development | On-time, on-budget delivery of new 503B facilities from greenfield to first production |
Automation ROI | Cost-per-unit reduction and throughput gain attributable to automation implementations |
Production Throughput | Batch output volume, capacity utilization, and on-time release rates across network |
Regulatory Compliance | FDA inspection readiness scores, CAPA closure rates, deviation trends |
Cost of Goods | COGS as % of revenue; waste reduction and yield improvement tracking |
M&A Integration | Time from deal close to stabilized production; integration milestone adherence; CapEx accuracy vs. due diligence estimates |
People & Retention | Voluntary attrition, leadership development progress, succession plan health |
REQUIRED TOOLS & RESOURCES
- Laptop, mobile device, and secure remote access to all operational and quality systems
- Travel budget supporting approximately 50% travel to facility and project sites nationwide
- Access to ERP/MES, QMS, environmental monitoring platforms, and executive reporting infrastructure
- Capital project management tooling and approved vendor relationships for construction and automation procurement