Carol Bye

Quality Assurance executive and enterprise-level leader with an exceptional strategic mindset and deep experience across all facets of Quality Assurance spanning the full pharmaceutical product lifecycle, from Research and Development through commercial manufacturing, at a top-tier BioPharma company.

Most recently Vice President, Head of Regulatory Quality Assurance at Pfizer, with global accountability for QA oversight of all regulated activities across 45 countries, a team of 180, and a USD $60M budget. Proven track record designing and enhancing risk-based audit strategies, risk management strategies, and best-in-class Quality Management Systems that deliver higher quality performance at lower cost across the globe.

Trusted advisor to executive leadership and the Board of Directors on Risk and Quality Governance, and a change leader adept at building and developing highest-performing teams through significant change.

Key skills include:

• Enterprise Quality Management Systems (QMS)
• Risk-Based Audit Strategy & Execution
• GMP Quality Assurance & Compliance
• Regulatory Inspection Management
• Risk & Quality Governance
• Clinical, Pharmacovigilance & Pre-Clinical Quality

• Technical Transfer to Commercial Manufacturing
• External Manufacturer & Supplier Quality Oversight
• Strategic & Change Leadership
• Multidisciplinary Team Leadership & Development
• Small Molecule, Biologics, Vaccine & Device
• Global Multi-Site Operations