Steve Mann
Associate Director, Quality Technical Services | Kymanox | Your Life Science Solutions Partner
- Role
- Associate Director at Kymanox
- Location
- Clayton, NC, US
- LinkedIn followers
- 500 followers
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.
Experience
Associate Director
Jun 2024 — Present · 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
2007 — 2009
Skills
- Technology Transfer
- Biopharmaceuticals
- Pharmaceutical Industry
- Sop
- Fda
- Glp
- Validation
- 21 Cfr Part 11
- V&V
- Computer System Validation
- Gxp
- Aseptic Processing
- Cleaning Validation
- Capa
- Change Control
- Gmp
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