VP of 503B Services

Vaga não está no LinkedIn

🕒 Agosto 21

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $150.000 - $200.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

👻 Score fantasma 20%

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Revelation Pharma

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2020

🏥 Saúde

🏭 Manufatura

💊 Farmacêutico

Healthcare • Manufacturing • Pharmaceuticals

A Revelation Pharma é uma rede nacional de farmácias de manipulação 503A e 503B, dedicada a oferecer preparações e serviços farmacêuticos inovadores e de qualidade. Eles têm como objetivo liderar o setor de farmácias de manipulação, focando em cuidados centrados no paciente e explorando oportunidades de crescimento e colaboração entre farmácias. Sua missão inclui o compromisso de melhorar o negócio farmacêutico e garantir uma transição suave para aqueles que desejam vender ou se associar a farmácias de manipulação respeitáveis.

Descrição

• Build, scale, and optimize Revelation Pharma’s 503B outsourcing facility network • Lead real estate evaluation and site selection for new 503B outsourcing facilities • Develop and own the facility development playbook and project governance standards • Manage capital projects from architectural programming and design review through construction, commissioning, validation, registration, and production launch • Partner with Regulatory Affairs on state Board of Pharmacy licensure, DEA registration, and federal 503B registration • Build business cases and capital expenditure requests with ROI modeling, capacity projections, and risk-adjusted timelines • Define and execute network automation strategy, including robotic dispensing, automated filling and finish systems, MES/ERP integration, and environmental monitoring • Lead automation vendor selection, contract negotiation, installation qualification, operator training, and change control • Establish technology standards and approved-vendor lists for compounding automation • Maintain FDA inspection readiness and oversee FDA Form 483 responses, warning letter remediation, and CAPA programs • Partner with Quality Assurance on SOPs, batch records, environmental monitoring, and deviation management • Own network-level production P&L and drive EBITDA performance through COGS, labor efficiency, throughput, and waste management • Lead production scaling across sites and develop production KPIs • Oversee lean manufacturing and continuous improvement programs including 5S, Kaizen, and Six Sigma • Align production scheduling with customer demand and communicate capacity constraints • Serve as operational SME for 503B-related M&A activity • Lead operational due diligence, acquisition valuation input, and post-acquisition integration • Build and lead the 503B operations organization, including Directors, Site General Managers, and project/engineering functions • Develop leaders through performance expectations, development plans, and coaching • Conduct regular site visits and partner with HR on compensation benchmarking, retention, and succession planning • Report directly to the COO

🎯 Requisitos

• PharmD, Bachelor’s degree in Pharmacy, or B.S./M.S. in Engineering required • 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 • 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 • Direct experience with FDA inspections, cGMP compliance programs, 21 CFR Parts 210/211, and USP chapters 795/797/800 required • Strong capital project management skills, including business case development, CapEx management, contractor oversight, and on-time/on-budget delivery • Proven people leadership experience developing multi-level teams and building leadership bench strength in complex, regulated environments • Strong financial acumen with experience owning operational P&L, managing capital budgets, and driving EBITDA performance • Exceptional executive presence and ability to represent 503B operations to regulators, health system customers, investors, and the Board • MBA or equivalent business training strongly preferred • Experience supporting or leading M&A activity in a pharmaceutical, compounding, or healthcare services context strongly preferred

🏖️ Benefícios

• 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 tooling • Approved vendor relationships for construction and automation procurement