Steve Mann
Associate Director @Kymanox
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WORK HISTORY
Associate Director @Kymanox
Raleigh-Durham-Chapel Hill, NC, US
Led Quality Technical Services engagements, providing strategic quality leadership to life sciences and CDMO clients. • Oversaw enterprise QMS elements, including deviations, non-conformances, and CAPAs, ensuring compliance with regulatory standards. • Established and governed quality policies and SOPs, aligning them with industry regulations to enhance operational efficiency.
EDUCATION
Thomas Edison State University
Bachelor of Science - BS, Engineering
SKILLS
ABOUT STEVE MANN
Dynamic quality and technical services leader with over 20 years of expertise in aseptic pharmaceutical manufacturing and GMP-regulated environments. Proven success in steering quality organizations, managing enterprise QMS programs, and ensuring readiness for FDA and EU inspections. Strategic thinker recognized for implementing risk-based compliance initiatives, driving audit remediation, and fostering operational excellence across multi-site operations. Committed to enhancing product quality and safety while optimizing processes to meet regulatory standards.
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