Fernando P. Munoz

About Fernando P. Munoz

A highly experienced Quality, Regulatory & Operations Leader taking quality teams to new levels of success in a variety of highly competitive industries, cutting-edge markets, and fast-paced environments, i.e. Gene Therapy, Pharmaceutical, Combination products, AI/ML algorithm development, SaMD, Robotics and electro-mechanical components. Accomplished Quality and Regulatory professional with 25+ years of progressive experience and a record of significant contribution in areas of quality management systems, design quality, product quality, post-market surveillance, GMP, project management, validation & verification, and supplier relationship management. Extensive successful experience working with regulatory agencies and customers globally. Exemplary external quality audit results. Specialties: • Aligning Resources with Strategic Plan • Operational Efficiency by Building High Performing Teams • Global Quality Compliance including EU MDR, Deviation/CAPA, Supplier Management, Design Quality, Quality Control and Quality Auditing • Quality and Business Process Mapping • Successful Global Regulatory Submissions • Business Process Mapping • Organizational and Talent Development • Building Competency through Process Improvement • Implementation of APQP and PPAP methodologies

Experience

1. Supplier Quality Manager

   Pfizer

   Jun 2023 — Present · Sanford, NC, US

   Manage the Gene-Therapy and Vaccines supply base by being a liaison with critical suppliers, providing product Quality oversight, maintaining supplier controls, generating supplier quality metrics, and monitoring the effectiveness of supplier corrective and preventive actions to resolve non-conforming issues- Responsible for the operational and strategic management of the Supplier Quality Management operations to support Commercial and Clinical manufacture of Gene-Therapy and Vaccines products- Drive regulatory excellence, to ensure supply of raw materials which are compliant with regulatory requirement (21 CFR 210, 211)- Manage department budget, resource planning, supplier quality performance metrics tracking, quality strategic planning and objectives, and Continuous Improvement projects- Lead and drive a Quality mindset across the supplier quality stakeholders and site leadership team- Manage of Suppler Quality documentation, risk and technical assessments, vendor related documentation, material qualification packages, and audit reports associated with clinical and commercial processing, while ensuring adherence to regulatory agency requirements, Pfizer standards, policies and values.

Education

• Atlantic International University

  MS, Quality Control

  1999 — 2000

• California State University, Fullerton

  MBA, Finance

  2002 — 2004

• Tecnológico de Monterrey

  Bachelor of Science, Industrial and Systems Engineering

  1994 — 1998

• UC San Diego

  Certificate, Project Management

  2017 — 2019

• University of Massachusetts Lowell

  Doctor of Philosophy - PhD , BioMedical Engineering