- 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 (Good Automated Manufacturing Practice – Software license certs)