@kenriley
Senior VP of Professional Services at DWAI, supporting FDA-compliant medical lab operations and life-science services.
United StatesAt DWAI, I support life-science and medical lab operations through professional services management and FDA audit compliance. I lead cross-functional teams and coach project managers working on product and computer-based system delivery.
My work includes coordinating process characterization and validation plans, supporting quality assurance, and improving operations. At NTT and Physical Optics Corp, I headed a team that secured a relationship for the Federal DIQ ITES-3 contract vehicle.
Work history, roles, and key accomplishments
DWAI
Jan 2013 - Present (13 years 9 months)
Advisor and FDA Audit Compliance Engineer for life-science medical lab operations, managing over $500M in contracts and leading cross-functional teams.
NTT Physical Optics Corp
Jan 2007 - Dec 2013 (6 years 11 months)
Headed technology operations and compliance for federal contracts, including the DIQ ITES-3 $12.6B contract vehicle, and supported capture plans for engineering infrastructure and supply-chain management.
Hughes Medical Foundation
Directed professional services with budgets ranging from $10M to $20M.
California Medical Lab Operations & Technologies Corp
Directed engineering for medical lab operations and technologies.
Allied-Signal
Designed and implemented global SAP supply-chain systems across China, South America, and Europe.
Seagate Corporation
Senior role in global life-science medical lab operations and processes technology.
EG&G Incorporated
Directed professional services with budgets ranging from $10M to $20M.
DSCI
Led government compliance and quality management, winning SBIR awards for NIH-CDC research and development.
Degrees, certifications, and relevant coursework
MS/eMBA, Operations Management
Earned an MS/eMBA in Operations Management from ABHEC University in 2005.
Bachelor of Science, Systems Engineering / Technology Management
Completed a Bachelor of Science in Systems Engineering and Technology Management from California State University, Long Beach in 1990.
Applied Science Degree, Science
Earned an Applied Science degree in Science from Portland Community College in 1985.
Certification, Contracts / Professional Services Management
Completed a certification in Contracts and Professional Services Management from American Graduate University.
Certification, Professional Services Operations Productivity Management
Completed a certification in Professional Services Operations Productivity Management from UCLA and CSUF.
Certification, Professional Services Operations Productivity Management
Completed a certification in Professional Services Operations Productivity Management from UCLA and CSUF.
United StatesYou can contact Ken and 90k+ other talented remote workers on Himalayas.
Message KenSign up now and join over 250,000+ remote workers who receive personalized job alerts, curated job matches, and more for free!
Sign up now and join over 250,000+ remote workers who receive personalized job alerts, curated job matches, and more for free!
Join the remote work revolution
Himalayas is the best remote job board. Join over 250,000+ job seekers finding remote jobs at top companies worldwide.
Anupama Nagaraja
Consultant, Self Employed
Brice Williams
Principal Consultant – Quality Systems & Regulatory Compliance, Axiom Consulting Group
REINA User
QA/QC Project Manager, Syensqo
Francisco Buella
Director, Pharma Project Management, Network Partners Group
Mereena Kurien
Manager, Global Quality Systems, Alimera Sciences
Tim Bryant
Account Executive, Strategic Healthcare Programs, Siemens Healthineers
Angela Adams
Director, Global Study Management, Fresenius Medical Care North America
Kurtis Montegna
Senior Director, Global Quality, Regulatory & Clinical Affairs, Danaher | Beckman Coulter Diagnostics
Dixita Amin
Quality Assurance Team Lead, Abbott Diagnostics
Angela B
Senior Group Leader, Thermo Fisher Scientific