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25 days old

Vice President - Computer System Validation and Information Technology â??

Kelly Services
Raleigh, NC 27608
**Vice President - Computer System Validation and Information Technology Raleigh, NC**



**Direct Hire**



**Job Summary:**




+ Develop and champion Computer System Validation & Information Technology strategies to support the business strategy of continued growth, improved efficiency and improved quality of life for employees.

+ Core to the CSV & IT strategy is an enterprise model which enables a consistent service delivery across all locations.

+ The enterprise model is achieved through delivery of CSV & IT as a service and utilizes standardization, harmonization and automation to achieve efficiency.

+ Extensive collaboration with business leaders is required to understand business needs and develop appropriate support and a relevant project portfolio.

+ Project Portfolio Management is an ongoing responsibility and must adjust as business needs and priorities change.

+ Ongoing communication with business leaders maintains a mutual understanding of project priorities, progress towards delivery of systems and/or instruments and any issues that may arise.

+ Ongoing maintenance of GMP compliant status for all GMP systems is essential.

+ High availability of all systems, including IT infrastructure components such as the network, compute and storage, is necessary due to the 24x7 nature of the operation. In the role of business liaison, system ownership and system execution strategy development are mission critical as strategy development gathers multiple line-of-business and/or location needs and perspectives into a coherent execution plan.

+ Consistent with delivery of CSV & IT as a service is the need to pursue continuous improvement improving tools, technology, people and systems in pursuit of business efficiency.

+ The CSV & IT Project Management Office is focused on business-driven projects with IT elements.

+ Many business-critical projects require process mapping, SOP development and related training as part of the go-live effort.

+ The CSV & IT PMO provides a centralized approach to improving overall project efficiency as well as governance and structure to program management and project portfolio management.

+ The CSV & IT PMO supports, mentors and develops program managers who are directly responsible for internal projects.,

+ The CSV & IT Leadership Team (System Owners, PPM, PMO, IT Operations, Computer System Validation, Lab Support, System Administration, Application Architecture and IT Infrastructure Architecture) establishes, plans, and administers the overall policies and goals for the computer system validation and information technology department.

+ Support, mentor and develop CSV & IT Staff.

+ Executive leadership and collaboration for CSV & IT Strategy Development.

+ Strategy execution through Project Portfolio Management and Project Execution.

+ 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.

+ High Availability necessitates appropriate monitoring tools and utilization.

+ Secure the environment against any data loss and any unapproved access. Prepare and respond to any regulatory or customer audits or inspections.



**Experience:**




+ Bachelors degree in Computer Science, a related field or equivalent experience, with a minimum of 20 years of delivering technology as a service which includes, but is not limited to, IT Strategy, IT Systems Design, IT Systems Deployment, IT Systems Operation, service level support, service desk management and administration.

+ Experience must also include Project Portfolio Management and Project Management Office to facilitate business collaboration and effective execution of projects.

+ A background in 21 CFR Part 11 environments is also required. Understanding, development and compliance with SOPs is required. Understand SOPs, deviations, corrective actions and controlled documents is a daily responsibility.

+ A background in industrial engineering, continuous process improvement or six sigma is desirable.

+ A background in manufacturing execution systems is desirable.

+ A background in analytical development instruments is desirable.

+ Interprets and applies complex technical information; knowledge of systems design and implementation in a database environment; knowledge of technical and user-related aspects of a personal computer environment. Skill in creative and adaptive program planning design, implementation, maintenance, and evaluation is required.



If you are interested in this role, then please feel free to reach out directly to: **vidhi.kundalia@kellyit.com** or 720-201-3798










**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.

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Posted: 2020-07-20 Expires: 2020-08-20

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Vice President - Computer System Validation and Information Technology â??

Kelly Services
Raleigh, NC 27608

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