Michael Kahsai
Senior Vice President, Global Head QA/QC at Novavax
- Role
- Senior Vice President, Global Head Qa Qc at Novavax at Novavax
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Michael Kahsai
Specialties: Senior QA/QC Leadership, Product Life Cycle Management, Sterile/Aseptic Manufacturing, Interpersonal skills, Data integrity, Global Analytical Control Strategy, Lean Principles & continuous improvement, QA system Automation, QA system deficiency remediation, Comprehensive QA system gap assessment, Development & Implementation of QA systemsLEADERSHIP HIGHLIGHTS Led over 150 employee with an annual operating budget of over $34MM in the commercial & clinical development space. Served an integral role supporting product commercialization, with a record of success that includes 3 BLA submissions and first time approval & over a dozen IND submissions. A history of innovation that includes the deployment of robust LIMS & ELN systems, as well lab automation initiatives to transform laboratory documentation into a paperless systemUNIQUE VALUE PROPOSITION delivers solid results in pharmaceutical operations management, with well over two decades of experience in leadership roles guiding quality, regulatory compliance, policy development, and other key areas for industry leading Fortune 500 corporations. Success is driven by the ability to build clinical and commercial quality strategies, global quality systems, policies and procedures to govern laboratories, equipment, software, and global analytical control strategy.SUMMARY Engaging Pharmaceutical Operations Executive possessing a winning blend of team leadership, strategic talent, and communications acumen. Skilled in managing large, complex enterprise services to produce exemplary results, via hands-on involvement and cross-functional delegation. Leverages a unique mix of visionary, strategic, operations and analytical expertise, consistently exceeding revenue and performance goals by aligning staff talents and effort with organizational objectives. An influential leader who creates immediate impact, produces results and fuels profits.
Experience
Senior Vice President, Global Head Qa Qc at Novavax
Dec 2021 — Present · Gaithersburg, MD, US
Education
University of Kansas Medical Center
Ph.D., Biochemistry/Molecular Biology
1990 — 1994
University of Nebraska-Lincoln
Master of Science (MS), Biochemistry
South Dakota State University
Master of Science (MS), Analytical Chemistry
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