Validation Manager - Cordova, TN
Job Title: Validation Manager
Location: Cordova, TN 38016
Duration: 6-months contract
- 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
- 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:
- Bachelor’s degree in a Computer, Science, Engineering or related field, or an equivalent combination of training and experience.
- Any certifications related to quality systems, GxP and computer systems validation beneficial
- 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.
United States of America
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Job Title: Validation Manager
Location: Cordova, TN
Job Type: Temp Position
Reference ID: 361835
Posted Date: 4/1/2019