VP of 503B Services

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, expand, and enhance Revelation Pharma’s network of 503B outsourcing facilities.

• Oversee the evaluation of real estate and the selection of sites for new 503B outsourcing facilities.

• Create and maintain the facility development playbook along with project governance standards.

• Manage capital projects from initial architectural programming and design review to construction, commissioning, validation, registration, and production launch.

• Collaborate with Regulatory Affairs on state Board of Pharmacy licensure, DEA registration, and federal 503B registration processes.

• Construct business cases and capital expenditure requests, complete with ROI modeling, capacity forecasts, and risk-adjusted timelines.

• Define and implement a network automation strategy, which includes robotic dispensing, automated filling and finishing systems, MES/ERP integration, and environmental monitoring.

• Lead the selection of automation vendors, negotiate contracts, and oversee installation qualification, operator training, and change control processes.

• Establish technology standards and a list of approved vendors for compounding automation.

• Ensure FDA inspection readiness and manage FDA Form 483 responses, warning letter remediation, and CAPA programs.

• Collaborate with Quality Assurance on SOPs, batch records, environmental monitoring, and deviation management.

• Own the network-level production P&L and enhance EBITDA performance through effective management of COGS, labor efficiency, throughput, and waste reduction.

• Spearhead production scaling across multiple sites and develop production KPIs.

• Oversee lean manufacturing and continuous improvement initiatives, including 5S, Kaizen, and Six Sigma methodologies.

• Align production scheduling with customer demand and communicate any capacity constraints.

• Act as the operational subject matter expert for 503B-related M&A activities.

• Lead operational due diligence, contribute to acquisition valuation, and manage post-acquisition integration.

• Build and manage the 503B operations team, which includes Directors, Site General Managers, and project/engineering roles.

• Foster leadership among team members through performance expectations, development plans, and coaching initiatives.

• Conduct regular site visits and collaborate with HR on compensation benchmarking, retention strategies, and succession planning.

• Report directly to the COO.

⛳️ Requirements

• PharmD, Bachelor’s degree in Pharmacy, or B.S./M.S. in Engineering is required.

• At least 10 years of progressive leadership experience in 503B outsourcing pharmacy, pharmaceutical manufacturing, or high-volume sterile compounding, demonstrating multi-site accountability.

• Proven history of establishing or scaling 503B outsourcing operations across multiple locations.

• Direct experience managing facility development from site selection through regulatory registration and production launch.

• Hands-on experience overseeing construction, cleanroom design, and the commissioning of USP 797/800-compliant facilities, including IQ/OQ/PQ and FDA outsourcing facility registration.

• Demonstrated ability to identify, select, and implement automation in compounding or pharmaceutical manufacturing settings.

• Direct experience with FDA inspections, cGMP compliance programs, and 21 CFR Parts 210/211, as well as USP chapters 795/797/800 is required.

• Strong skills in capital project management, encompassing business case development, CapEx management, contractor oversight, and the ability to deliver projects on time and within budget.

• Proven leadership experience in developing multi-level teams and fostering leadership capabilities in complex, regulated environments.

• Solid financial acumen with experience managing operational P&L, capital budgets, and driving EBITDA performance.

• Exceptional executive presence and the ability to represent 503B operations to regulators, health system customers, investors, and the Board.

• MBA or equivalent business training is strongly preferred.

• Experience in supporting or leading M&A activities within a pharmaceutical, compounding, or healthcare services context is strongly preferred.

🏝️ Benefits

• Laptop.

• Mobile device.

• 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 tools.

• Established vendor relationships for construction and automation procurement.