Douglas Silber

Senior leader with 20+ years of management experience. Holds an MBA with a concentration in Human Resource Management.

Expert in all aspects of Quality Management, Program Management and Project Management with experience executing multi-function management and business analysis for a variety of projects and organizations. Excellent organizational, planning, time-management and problem-solving abilities.

I am a senior quality management leader with over 20 years of experience in quality assurance, regulatory compliance, CAPA management, and training development within medical devices, pharmaceuticals, and biologics industries. I have successfully led global teams, developed and implemented Quality Management Systems (QMS), and managed corrective and preventive actions (CAPAs) to drive continuous improvement.

My expertise includes

• Quality Assurance & Compliance: Led 300+ CAPA investigations, conducted 25+ internal and external audits, and managed regulatory compliance in FDA-regulated industries.
• Process & Risk Management: Developed root cause analysis (RCA) and CAPA training programs, ensuring compliance with ISO, FDA, GMP, and USP standards.
• Leadership & Training: Managed teams of 30+ professionals, created training programs, and implemented standard operating procedures (SOPs) for sterile and non-sterile environments.
• Strategic Quality Initiatives: Successfully established new QMS, optimized QA/QC programs, and improved audit readiness and compliance at multiple organizations.

My experience with Medtronic, Abbott, Philips Respironics, and other leading healthcare companies demonstrates your ability to lead quality teams, ensure regulatory compliance, and drive operational excellence in complex, highly regulated environments.

My most relevant education includes:

MBA – Master of Business Administration (Human Resource Management)

Saint Leo University, Tampa, FL

• Provides strong leadership, strategic planning, and management skills essential for overseeing quality assurance teams, compliance programs, and training initiatives.

BA – Bachelor of Business Management (Summa Cum Laude)

Saint Leo University, Tampa, FL

• Offers a solid foundation in organizational management, process optimization, and regulatory oversight, supporting your expertise in quality systems and compliance.