Jwalant Vyas

About Jwalant Vyas

A seasoned biopharmaceutical executive with over 20 years of global leadership experience across Manufacturing (internal & external), Quality, Supply Chain, Operational Excellence, and Digital Transformation. Demonstrated ability to integrate operational expertise, regulatory compliance, financial acumen, and digital innovation to drive enterprise-scale impact across U.S. and international markets- Selected for and graduated from Amgen’s highly selective FUEL FOL (Operations Leadership Program), reflecting strong executive potential & readiness- Recognized for excellence in organizational planning, strategy execution, financial performance, and people leadership- Extensive experience leading cross-functional initiatives across large molecule, small molecule, and combination product operations- Broad-based expertise in Biopharmaceutical Operations including: Manufacturing (Small & Large Molecule), Product Commercialization, Product Technology Leadership, Product Operations Leadership, Clinical & Commercial Supply Chain, Tech Transfer, Quality Operations, Automation, Quality Systems, Supplier QA, Vendor Evaluations, Audits & Inspections, Compliance, Device & Combination Product, Facilities & Engineering, QC Lab Processes, Process Engineering, Product Lifecycle Management, Digitization, AI/ML applications and AI/ML Ops in operations- Deep knowledge of global quality and regulatory standards, including 21 CFR Parts 11, 211, 820; EMEA Annex 11; ICH Q7–Q11; IEC 62304; PIC/S; FDA guidance for computerized systems in GxP environments; GAMP; Data Integrity standards; GMP & GDP- Proven track record in Financial Analysis, Budgeting, Cost of Goods Manufactured (COGM), Variable Cost Productivity (VCP), and Lean/OE transformation- Experienced in developing and executing short- and long-term business strategies, with a focus on measurable outcomes and sustainable growth- Strong leadership in building high-performing teams and driving organizational change. Effective mentor and communicator with a collaborative approach to solving complex business challenges- Combines operational depth, strategic foresight, and digital transformation capabilities to create intelligent, resilient, and patient-centric biopharmaceutical enterprises.

Experience

1. Senior Director Digital Quality Operations

   Merck

   May 2023 — Present

Education

• Gujarat University

  Bachelor's degree, Chemical Engineering

  1995 — 1999

• Illinois Institute of Technology

  Master of Science (M.S.) - Dual Major, Chemical Engineering and Computer Science

  2000 — 2002

Skills

• Change Control
• Gxp
• Aseptic Processing
• Computer System Validation
• V&V
• Quality Assurance
• 21 Cfr Part 11
• Sop
• Fda
• Capa
• Gmp
• Biotechnology
• Biopharmaceuticals
• Validation
• Cross-Functional Team Leadership
• Data Integrity Assurance Program , Process & Assessment
• Sdlc
• U.s. Food and Drug Administration (Fda)