Vice President of IT and CSV; Pharma; Durham, NC
Kelly Technology is looking for a Vice President of IT and CSV
for a direct hire role open with our biotech client in Durham,
Title: VP of IT and Computer System Validation
Location: Durham, NC or Boulder, CO
Very Competitive Compensation Package
Lead Computer System Validation, IT and CyberSec teams in GxP
Develop CSV and IT strategies and lead and monitor Project
Portfolio Management and Project Execution.
Responsible for consistent service delivery across all
organization with a focus on continuous improvement & innovation
and compliance with FDA and other regulatory agencies.
Directing implementation of effective IT service operation and
Secure GMP compliance through effective Computer System
Validation execution & High Availability of all systems, including
IT Infrastructure, across all locations.
Anticipates future needs through proactive capacity management
Secure the environment against any data loss and any unapproved
Initiate internal audits; prepare and respond to any regulatory
or customer audits or inspections.
A minimum of eight (8) years’ experience in the Life Science
industry. Biopharma/Biotech preferred.
8 years minimum experience enforcing GMP compliance through
effective Computer System Validation execution and availability of
all systems, including IT Infrastructure & Security, across
Strongly preferred: ITIL Certified of CGEIT,
in IT role managing CSV processes and procedures, IT
Infrastructure and IT Security.
2+ years of experience performing and developing CSV and/or
Extensive knowledge of CSV, GAMP 5, Data Integrity and 21 CFR
Practical application of CSV Industry Standard Best Practices
Hardware & Software:
Experience validating and enforcing compliance for following
types of systems is required:
ERP Systems (SAP preferred)
Process Control Systems
Building Management Systems
Databases and Data Warehouses
Other enterprise systems such as CMMS, etc
Minimum Bachelor of Science in Computer Science/Computer
Engineering or similar, Master’s degree preferred.
By partnering with Kelly® Technology, you’ll have direct
connections to top companies around the globe—giving you the chance
to put your tech skills to work on some of today’s most intriguing,
innovative, and high-visibility projects. In a world where change
is the only constant, our unparalleled connections and IT market
expertise help you take your skills exactly where you want to go.
We’re here to help you gain experience, keep learning, and move
your career forward.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising
job seekers on new ways of working to reach their full potential.
In fact, we’re a leading advocate for temporary/nontraditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live. Connecting great people with great companies is what we
do best, and our employment opportunities span a wide variety of
workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a
diverse workforce, including, but not limited to, minorities,
females, individuals with disabilities, protected veterans, sexual
orientation, gender identity. Equal Employment Opportunity is The
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