Steve Mann

Associate Director @Kymanox

Clayton, NC, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2024 — Present

Associate Director @Kymanox

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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

2007 — 2009

Thomas Edison State University

Bachelor of Science - BS, Engineering

SKILLS

Technology TransferBiopharmaceuticalsPharmaceutical IndustrySopFdaGlpValidation21 Cfr Part 11V&VComputer System ValidationGxpAseptic ProcessingCleaning ValidationCapaChange ControlGmp

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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