VP, IT & CSV

MS in Computer Science, a related field or equivalent experience, with 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 Manufacturing execution systems and analytical development instruments knowledge 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
Full Time
BASED ON EXPERIENCE

Job Description

Job Req #: #: 20-06244
Job Description: Vice President, IT and CSV
Location: Durham, NC
Position Type: Full-time, Direct Hire, W2 only

s and s are welcome to apply. We are unable to process an H-1B. Please note that my client is looking for someone who has worked in a heavily regulated industry, such as pharma, aerospace, etc. The successful candidate will have heavy experience with agile, the cloud and digital transformation.

Key Responsibilities:

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 business locations. The enterprise model is achieved through delivery of CSV & IT as a service to the company 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 necessities 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

Qualifications:
  • MS in Computer Science, a related field or equivalent experience, with 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
  • Manufacturing execution systems and analytical development instruments knowledge 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

Diane Douglas
Recruiting Manager/Senior Technical Recruiter
303-694-5493

About Ascent:
The Ascent Services Group (ASG) is a nationally recognized technology staffing and consulting firm whose fundamental business is providing staffing services to Small, Medium, and Large Enterprise clients in our core market verticals: Financial Services, Healthcare, Technology and Life Sciences. As consultants for ASG, you will have access to many of the top clients within the industries we serve. Our goal is to deliver innovative talent through proven best practices and effective resource optimization. Become one of ASG's candidates and experience the difference!
IND05

Posted By

Diane Douglas

Dice Id : itca001
Position Id : 20-06243
Originally Posted : 2 months ago
Have a Job? Post it

Similar Positions

IT Director
  • Zachary Piper Solutions, LLC
  • Raleigh, NC
IT Project Manager- Software Development
  • MATRIX Resources, Inc.
  • Durham, NC
Implementation Project Manager
  • Eliassen Group
  • Raleigh, NC