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Job Title:

Validation Manager - Cordova, TN

Job Description:

Job Title: Validation Manager
Location: Cordova, TN  38016
Duration: 6-months contract

 

Job Descriptions:

  • Responsibilities The Consultant IT Computer Systems Validation Manager is to insure that the global IT organization is in compliance with all applicable healthcare laws and regulations with a focus on computer systems validation.
  • The role requires good communication skills to be able to work with a wide variety of IT and non-IT staff at various sites around the world.
  • The Consultant IT Computer Systems Validation Manager is also responsible for coordinating and facilitating internal and external audits of IT.
  • In this role it is necessary to work with auditors in addition to Regulatory, Quality, Finance, IT and other personnel as required. Post-audit requirements include following up on audit findings and working with the appropriate staff to remediate all findings

 Relationships:

  • Work and partner with IT and Business leaders, external audit partners/directors and be able to interface directly with senior management when necessary.
  • Earn and maintain confidence of their core customers, both inside and outside of the group, to foster teamwork and support the vision and goals of the IT organization.

 Responsibilities: (Please specify % amount against each responsibility)

  • 60% Provide consultation and governance in the areas of regulatory requirements and Computer System/Software Validation
  • 20% Coordinate and manage global IT efforts toward compliance with the Quality System Regulation and non-product Computer Software Validation in compliance with regulations such as FDA CFR 21 Part 820 / Part 210 / Part 211 / Part 11 and ISO 13485.
  • This role includes advising IT and the user community what falls under these regulations and helping to coordinate efforts toward compliance with them
  • 5% Work with internal and external auditors to facilitate all IT components of regulatory audits.
  • This includes setting up schedules, providing work spaces, acting as the facilitator and escort for audits, and working with global sites to plan and execute audits at individual sites.
  • 5% Perform internal and/or external audits of IT sites to insure compliance with IT CSV procedures and applicable regulations.
  • 10% Support and adhere to all IT policies, procedures and standards, including but not limited to, IT Guiding Principles, Project Management, Change Management, Internal and External Compliance such as Health & Safety, Quality, Regulatory and Finance, and support of Internal and External Audits

 Experience & Knowledge Essential Education:

  • Bachelors degree in a Computer, Science, Engineering or related field, or an equivalent combination of training and experience.

 Licenses/ Certifications:

  • Any certifications related to quality systems, GxP and computer systems validation beneficial

 Experience:

  • At least 12 years in Information Technology with at least 5 years of that in supporting and/or managing IT Quality Computer System/Software Validation delivery and oversight.
  • Significant experience of Cloud computing in a healthcare environment, computer systems validation within an Agile environment and the GAMP 5 framework.

Job ID:
361835

Dept ID:
10601

Location:
Cordova, TN
United States of America

Industry:
Online / Full App

Job Type:
Temp Position
Folder Group ID
258

Posted Date:4/1/2019

Domain:arna

Contact: saubhik.samant@advantageresourcing.com

Apply for this Position

Job Title: Validation Manager

Location: Cordova, TN

Job Type: Temp Position

Reference ID: 361835

Posted Date: 4/1/2019

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