Sharis Hazel
Sr. VP of Quality, Regulatory Affairs and Operational Excellence. Experienced Quality Assurance and Regulatory Affairs Leader with Six Sigma and ASQ certifications. Zeta Phi Beta Sorority, Incorporated.
- Role
- Vice President of Quality and Regulatory Affairs at Proesis Biologics
- Location
- Birmingham, AL, US
- LinkedIn followers
- 500 followers
About Sharis Hazel
With more than 20 years of experience in the pharmaceutical and biologics industry, I lead enterprise-wide quality, regulatory, and operational excellence strategies that safeguard product integrity, regulatory compliance, and patient safety. I provide executive oversight of quality systems, regulatory affairs, GMP compliance, and continuous improvement initiatives that support the development and delivery of life-saving biopharmaceutical therapies.My background includes extensive expertise in FDA regulations, GxP environments, change management, documentation systems, and cross-functional operational alignment. I am deeply committed to building sustainable quality cultures, strengthening inspection readiness, and driving performance through data-driven decision-making and Lean methodologies.I hold a Lean Six Sigma Green Belt, ASQ Certified Manager of Quality/Organizational Excellence, and ASQ Certified Quality Auditor certifications. I earned a Bachelor of Arts in Communication with a specialized focus in Healthcare Management from Southern New Hampshire University.Beyond my professional work, I am an active member of Zeta Phi Beta Sorority, Incorporated, and organizations dedicated to advancing equity, leadership development, and empowerment within minority communities.
Experience
Vice President of Quality and Regulatory Affairs
Jan 2024 — Present
Education
South University Savannah GA
Business Administration and Management, General
Southern New Hampshire University
Bachelor of Arts - BA, Communication, Healthcare Management
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