14 days old

Vice President of IT and CSV; Pharma; Colorado or North Carolina

Kelly Services
Denver, CO 80238
_Kelly Technology is looking for a Vice President of IT and CSV for a direct hire role open with our biotech client with offices in Colorado, North Carolina and Texas._

**Title:** VP of IT and Computer System Validation

**Direct Hire**

**Mid-Size Biotech**

**Location: Durham, NC or greater Denver, CO**

**Competitive Compensation Package**

**Sign-in Bonus**

**Job Summary:**

Lead Computer System Validation, IT and Digital Transformation 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.


+ **VP of IT or CIO experience in the Life Science, or Food Manufacturing or other FDA-regulated industries.**

+ 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.

+ Experience in Digital Transformation.

+ 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:



+ 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


Minimum Bachelor of Science in Computer Science/Computer Engineering or similar, Masters degree preferred.

_Interested in this role? Please feel free to reach out directly Tina Zahradnik, PHR at_ **_tina.zahradnik@kellyit.com_** _or 720-315-1387_

**Why Kelly** **** **?**

By partnering with Kelly Technology, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays 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. Were here to help you gain experience, keep learning, and move your career forward.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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.
Posted: 2020-09-14 Expires: 2020-10-22

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Vice President of IT and CSV; Pharma; Colorado or North Carolina

Kelly Services
Denver, CO 80238

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