Sree Vadlamudi
Senior Pharmaceutical Manufacturing Executive
Senior pharmaceutical manufacturing executive with 30 years of experience building sterile and non-sterile operations from the ground up — now advising companies on facility design, regulatory readiness, and operational execution that bridges boardroom vision with shop-floor results.
Built and scaled sterile and non-sterile manufacturing operations from the ground up across multiple continents.
Led multi-site pharmaceutical organizations through FDA inspections, MHRA audits, and EU GMP compliance with zero critical findings.
Directed facility startups from site selection through commercial launch — managing cross-functional teams of 200+ across engineering, quality, and operations.
Negotiated and integrated M&A transactions, aligning manufacturing strategy with board-level P&L objectives.
Established CDMO relationships and contract manufacturing networks that reduced COGS by 20–35% while maintaining supply chain resilience.
Designed and implemented Lean and Six Sigma programs resulting in measurable OEE improvements across sterile fill-finish lines.
Served as primary liaison to FDA, MHRA, and international regulatory bodies — authoring responses, hosting inspections, and driving remediation.
Defined and executed digital manufacturing roadmaps integrating MES, ERP, and real-time quality systems.
Mentored and developed VP- and Director-level operations leaders across global manufacturing sites.
Translated complex regulatory and operational challenges into clear executive strategy for boards, investors, and C-suite stakeholders.
GMP Facility Design, Build & Startup
Pharmaceutical Operations Leadership (Rx / OTC / 503a / 503b / Device / Cosmetics)
Sterile Manufacturing
End-to-End Facility Development
Regulatory Excellence (FDA / MHRA / EU / ISO / ICH Q8–Q10)
Organizational Transformation & M&A Integration
Supply Chain Optimization & CDMO Expansion
Board & CxO-Level Reporting / P&L Ownership
Lean / Six Sigma / Digital Manufacturing
Let’s Connect
Available for advisory roles, board positions, and consulting engagements in pharmaceutical manufacturing and regulatory strategy.
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