Venkata Gadamsetty

Pharmaceutical, Cosmetic, and Dietary Supplement executive with 30+ years of global experience spanning R&D, Product Development, Quality, Regulatory, and large-scale Plant Operations. Proven record leading ANDA, OTC, and nutraceutical portfolios; managing multi-continental CMO/CDMO networks; and driving multimillion-dollar cost savings through advanced process re-engineering. Expert in QbD, DoE, tech transfer, scale-up, and end-to-end operational excellence.

Known for people-centric leadership, rapid turnaround execution, and building high-performance, compliant, and audit-ready organizations.

Network Member at Gerson Lehrman Group (GLG) (2025-12 – Present)

• Provide strategic technical leadership for global product launches, regulatory alignment, and commercialization.
• Mentor SMEs across Oncology, GLP-1, Hormonal therapies; drive due diligence and cross-functional precision.
• Direct multimillion-dollar project plans, budgets, and ANDA-aligned development pathways.
• Lead CMO/CDMO selection, supplier qualification, and global sourcing strategy.
• Establish enterprise QA governance, SOP frameworks, and surveillance audit programs.
• Implement KPI-driven operational excellence and quality metrics.

Lead Associate – QA & Compliance at Dr. Reddy's Laboratories (2023-12 – 2025-11)

• Directed QA/QC systems for pharma and dietary supplements; ensured full FDA, GMP, and ISO 9001 compliance.
• Led internal/external audits with zero major findings; executed risk assessments and inspection readiness.
• Managed global CMO/CPO/CTL quality performance; authored Quality Agreements.
• Oversaw batch release, ingredient verification, and analytical integrity for complex portfolios.
• Reduced product defects 90% and improved team compliance 95% through SPC and targeted training.
• Built documentation systems for CAPA, OOS/OOT, deviations, and stability protocols.
• Partnered with Manufacturing, Supply Chain, and R&D to drive cost-efficient quality improvements.

Pharma, Cosmetic & Dietary Supplements Consultant at Independent Consultant (2023-06 – 2023-11)

• Led QbD-driven development using DoE/OFAT to optimize CMAs, CPPs, and CQAs.
• Directed plant operations, construction, utilities, equipment installation, and IQ/OQ/PQ qualification.
• Executed global tech transfers across US, Canada, EU, and India.
• Built robust QMS frameworks (Change Control, CAPA, Validation).
• Designed scale-up strategies improving manufacturability and commercial performance.
• Strengthened CMO partnerships and competitive benchmarking for market alignment.

Associate Director – Projects & Technical Services at Bionpharma Inc. (2020-01 – 2023-05)

• Directed 25+ concurrent projects from concept to commercial launch ($1M–$5M budgets).
• Integrated QbD and ANDA requirements into Product Development Plans.
• Led vendor negotiations and global stakeholder alignment.
• Mitigated technical risks and supported exhibit batch manufacturing.
• Co-Developed Intelence (Etravirine) equivalent via continuous clean & green fusion granulation.
• Implemented reporting frameworks for executive visibility and milestone tracking.

Pharma, Cosmetic & Dietary Supplements Consultant at Independent Consultant (2018-01 – 2019-12)

• Delivered 60% operational efficiency improvement through process re-engineering.
• Led parenteral QMS and documentation for injectables (sterility, E&L, CCI).
• Directed facility construction and qualification (IQ/OQ/PQ).
• Built enterprise compliance programs and risk-based decision frameworks.
• Managed plant operations using KPI-driven performance systems.

Director – Technical Operations at US Pharma Labs Inc. (2014-11 – 2017-12)

• Launched 26 products and stabilized 14 formulations using QbD/PAT.
• Achieved 45% productivity gains and $750K annual savings.
• Delivered 100% order fulfillment and zero backorders for 3 years.
• Managed global CMO operations (China, India) ensuring cGMP compliance.
• Reduced inventory discrepancies 40% and strengthened supply continuity.
• Led ERP implementation improving data accuracy and workflow efficiency.

Director – Scientific & Technical Affairs at Guardian Drug Company (2008-07 – 2014-10)

• Developed/launched 40 products, driving revenue from $22M to $120M (26% CAGR).
• Re-engineered 30 product lines, reducing conversion costs 40–60% and saving $2M annually.
• Qualified new vendors, reducing costs 30% and capturing $5M savings.
• Directed multimodal dosage development (oral, topical, nasal).
• Built and led QMS (CAPA, APR, Change Control) and authored regulatory responses.
• Strengthened compliance across ISO, GxP, FDA, HIPAA frameworks.
• Built global research partnerships and contributed to patent strategy.

Senior Manager – R&D and QA at Medico Labs Inc. (2003-07 – 2008-06)

• Developed and scaled 29 products, growing revenue from $0.5M to $8M.
• Managed CMO manufacturing for capsules and topicals; launched 7 products generating $2.6M.
• Led master formula, specification, and SOP development.
• Oversaw analytical method validation and QC operations.
• Improved supplier performance 95% through CAPA and root-cause analysis.
• Achieved zero major findings in FDA/GMP/ISO audits.

Ascending Roles to General Plant Manager at Warner Hindustan / SOL Pharma / SIRIS / Micro Labs / Medreich / Vivimed Labs (1984-05 – 2003-06)

• Led CMOs supporting Bayer, Sandoz/Novartis, SmithKline Beecham, Wyeth, LUPIN, CIPLA.
• Managed 50–400 personnel across production, QA, engineering, and supply chain.
• Passed TGA, RSA GMP, MHRA, WHO GMP, ISO audits.
• Developed oral solids, liquids, aseptics, intermediates, and sustained-release systems.
• Standardized processes for 70 herbal products.
• Co-developed novel shampoo-based hair dye with Hindustan Lever/Unilever Thai.

Bachelor of Pharmacy – Andhra University