Kenneth Shelley
Associate Director, Global Qms @United Therapeutics Corporation
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WORK HISTORY
Associate Director, Global Qms @United Therapeutics Corporation
RTP, NC, US
EDUCATION
North Carolina Agricultural and Technical State University
BS, Industrial Technology
DeVry Institute of Technology
Electronic Engineering
ABOUT KENNETH SHELLEY
Proven quality and compliance judgment, strong influential skills, leadership and general management plus a track record of developing and enhancing quality system processes. Ability to develop, plan and execute long-term strategies to business needs while executing short term requirements. Proven record to develop, manage, execute and continuously build quality systems to meet governmental regulatory requirements, i.e, cGMP-FDA 210 / 211 / 820, ISO 13485, ISO 9001, ICH, Japanese Pharmaceutical Affair Law (JPAL), and ISO 14971 Risk Management.Well-rounded quality discipline background utilizing Six Sigma, Lean Manufacturing, Kaizen and other continuous improvement initiatives and quality tools. Proficient in quality management and engineering, customer relations and complaint handling, GMP training and auditing, corrective/preventive action and investigation, supplier management, document control and change management, inspections, regulatory actions such as field action and recall, and validation and calibrations.Specialties: FDA, ISO, Risk Management, Supplier Management, Six Sigma, Kaizen, Lean Mfg, CAPA, Audit, QSR, Process Improvements, Quality Systems Development, ASQ Chair, etc.
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