Milton Hernandez

About Milton Hernandez

A patient-focused biopharmaceutical leader with expertise in transforming, developing and managing quality assurance, quality systems, compliance, operations, and logistics organizations. Change agent who actively seeks opportunities to influence and optimize processes to increase efficiency without compromising high quality standards. Diverse experience in Quality Assurance in biopharma and medical device HA inspections, audits, CAPA, supplier management and product complaints handling in accordance with international regulations such as FDA, MHRA, ISO/MDD and ICH guidelines. Decisive leader, influential coach/mentor who creates robust, scalable, team-oriented organizations that reward innovation and thrive on efficiency.

Experience

1. VP, Gxp Quality Systems, Compliance and Supplier Quality

   Galapagos

   Jan 2025 — Present · Princeton, NJ, US

   Head of GxP Quality Systems, Compliance and Supplier Quality provides leadership and expertise to support development of innovative and high-quality products from early phase to commercial for both internal and external suppliers of GxP materials and services provided to Galapagos.Lead a team of Quality professionals in executing and continuously improving a corporate wide Quality Management System (QMS). Accountable for global GxP QS, Compliance and Data Integrity, Quality Risk Management, Document Control, GxP Training, Internal Audit/Health Authority Inspections and Supplier Quality.Accountable for Quality Assurance, Compliance and Technical Support for Decentralized Manufacturing Units, lentiviral vector suppliers, Cocoon manufacturers, service providers, external contract laboratories, and CRO’s supporting Galapagos Clinical trials.Accountable for providing Quality support for technology transfer and improvement of manufacturing processes.Chair of Quality Management Review for Global Quality Systems & Compliance via KQIs and KPIs.Accountable for data collection, trend analysis trends, and for escalation of issues as appropriate to senior leadership and management committee when required.Accomplishment(s): led the redesign of key quality processes: Deviations, CAPA and Change Control including significant reconfiguration of Veeva e-system workflows to improve compliance and better align with 7-day CT vein-to-vein process, implemented a performance monitoring process for external vendors, implemented the internal audit process to ensure inspection readiness and redesigned the Quality Management Review process to improve tracking and trending on a rolling basis.

Education

• New Jersey Institute of Technology

  Bachelor of Science in Mechanical Engineering, Engineering

  1993 — 1999

• Stevens Institute of Technology

  Master of Science in Technology Management, Management

  2009 — 2011

Skills

• Gmp
• Quality System
• Deviations
• Quality Assurance
• Validation
• Isotrain
• Capa
• Iso 9000
• Gxp
• 21 Cfr Part 11
• Process Improvement
• Kaizen
• Dot Regulations
• 5s
• Trackwise
• Regulatory Requirements
• Manufacturing
• Lean Manufacturing
• Wms Implementations
• Continuous Improvement
• Cross-Functional Team Leadership
• Pharmaceutical Industry
• Fda
• Infinityqs
• Sip
• Lims