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Vice President of IT and CSV; Pharma; Durham, NC

Company: Kelly Services
Location: Durham
Posted on: September 13, 2020

Job Description:

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, NC.

Title: VP of IT and Computer System Validation

Direct Hire

Mid-Size Biotech

Location: Durham, NC or Boulder, CO

Very Competitive Compensation Package

Sign-in Bonus

Job Summary:

Lead Computer System Validation, IT and CyberSec teams in GxP environment.

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 execution methodologies.

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 and budgeting.

Secure the environment against any data loss and any unapproved access.

Initiate internal audits; prepare and respond to any regulatory or customer audits or inspections.

Skills/Knowledge/Abilities:

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 multiple locations.

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 conducting audits.

Extensive knowledge of CSV, GAMP 5, Data Integrity and 21 CFR Part 11

Practical application of CSV Industry Standard Best Practices Hardware & Software:

Experience validating and enforcing compliance for following types of systems is required:

LIMS

MES

ERP Systems (SAP preferred)

Process Control Systems

Building Management Systems

Laboratory Systems

Data Historians

Databases and Data Warehouses

Other enterprise systems such as CMMS, etc

Education

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 Law.

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Phone:

Email:

salesforce@kellyservices.com

Time Zone:

EST (Eastern Standard)

Area(s) of expertise:

All

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Keywords: Kelly Services, Durham , Vice President of IT and CSV; Pharma; Durham, NC, Other , Durham, North Carolina

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