Randall Obando

About Randall Obando

Seasoned, hands-on and data-driven Quality and Operations professional with experience in manufacturing, commercial and global technical service activities. • 25+ years of professional experience with a tracked record of outstanding performance proved by consistent career growth and correspondent increase on responsibilities. Experience includes medical device manufacturing start-up operations, quality/compliance remediation and company acquisition/integration activities. Appointed in several expat international assignments including Multi-site and multi-cultural roles.• Develop and implement business strategies globally to support cost reduction and new revenue streams to ensure external and internal customer satisfaction• Program management experience including successful product and technology transfers from design to manufacturing and service. • Develop and lead FDA inspection readiness initiatives and compliance remediation efforts. This includes warning letters and 483 responses and follow ups • Extensive experience in handling regulatory and quality inspections, including the FDA, MHRA and ISO Notified Bodies• Well-balanced quality professional with the unique experience of leading manufacturing operations for 24/7, people manufacturing lines• Tracked record of leading continuous improvement initiatives including Cost of Quality (COQ), Kaizen and Six Sigma projects. Led the Six Sigma teams for two medical device manufacturing operations. Worked cross functionally to develop the “case for quality” for different projects and organizations

Experience

1. Vice President, Quality Assurance and Regulatory Affairs (Bioproduction Group)

   Thermo Fisher Scientific

   Aug 2022 — Present

   As Vice President of Quality & Regulatory Affairs for Thermo Fisher Scientific’s Bioproduction Group, I direct QA/RA strategy across four divisions—Biologicals & Chemicals (BCD), Single-Use Technologies (SUD), Purification & Pharma Analytics (PPA), and Filtration & Separation (FSD)—leading a person team across 25 global manufacturing sites. I ensure our end-to-end bioprocessing portfolio (from single-use systems and Gibco cell culture media to chromatography resins, cGMP chemicals, and process analytics) meets the highest internal requirements and global regulatory standards. I partner closely with customers to co-innovate and strengthen quality, and I mobilize rapid, cross-functional responses when issues arise. I’ve supported growth through M&A due diligence and I’m spearheading an enterprise digital transformation, deploying AI-enabled tools to elevate compliance, risk management, and operational performance for pharma and biotech worldwide.

Education

• Instituto Tecnologico de Costa Rica

  Engineer's degree, Industrial Engineering

  1995 — 2000

• Interamerican University of Costa Rica

  Master of Business Administration (MBA), Industrial Management

  2005 — 2007

• Instituto Tecnologico de Costa Rica (FUNDATEC)

  Associate's degree, Industrial Electronics Technology/Technician

  1999 — 2001

Skills

• Quality Control
• Gmp
• Injection Molding
• Quality System
• Quality Assurance
• Validation
• Iso 13485
• Minitab
• Medical Devices
• Capa
• Manufacturing Operations
• Fmea
• Design Control
• Dmaic
• Manufacturing Engineering
• Change Control
• Six Sigma
• Quality Auditing
• 21 Cfr Part 11
• Value Stream Mapping
• Process Improvement
• Kaizen
• R&D
• Root Cause Analysis
• Facilities Management
• Design of Experiments
• Manufacturing
• Cqe
• Lean Manufacturing
• Testing
• Cqa
• Quality Management
• Continuous Improvement
• 21 Cfr
• Cross-Functional Team Leadership
• Supplier Quality
• Iso 14971
• Fda
• Fda Gmp
• Risk Management