SUMMARY
The main role of the IT Validation Lead is to ensure that IT computer system validations are delivered in compliance with all applicable laws and regulations within the framework of the IT PMO Solution Delivery Methodology. In order to facilitate these efforts, it is necessary to understand both the global organization and global regulations. 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.

ESSENTIAL FUNCTIONS

POSITION FUNCTIONS
  • Work closely with IT Project Teams to deliver Validation Documentation as required under the corporate Project Methodology.
  • Coordinate computer system validation efforts within the Quality System Regulation (21 CFR Part 820), Electronic Records; Electronic Signatures (21 CFR Part 11), 21 CFR Part 210/211 and local regulations. SOX and Data Privacy oversight may be required as well. This role includes advising IT and the user community what falls under these regulations and helping to coordinate efforts toward compliance with them.
  • Oversee and ensure adherence 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.

REQUIREMENTS

Travel:
Domestic/International – Up to 20%
Education:
Bachelor’s degree in Computer Science and/or Life Sciences; or an equivalent combination of training and experience.
Licenses/Certifications:
CISSP, CISM, CISA, CIPP or related certification highly recommended.
Experience:
At least 5 years supporting and/or managing Computer System/Software Validation; at least 2 years working in Information Technology.
Competencies:
  • Decision Making. Obtains information and identifies key issues and relationships relevant to specific goals; commits to a course of action to accomplish goals after developing alternatives based on logical assumptions, facts, available resources, constraints, and organizational values. Escalates decisions to next level where resolution cannot be found.
  • Building Working Relationships. Developing and using collaborative relationships to facilitate the accomplishment of work goals. Consultative in approach.
  • Improvement Focused. Thinks creatively outside the usual boundaries; questions the status quo; initiatives, drives and manages new ideas to achieve the IT vision and goals.
  • Gaining Commitment. Using appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one’s own behaviour to accommodate tasks, situations, and individuals involved.
  • Successful Team member. Supports and works effectively with others, internally and externally, to achieve common goals and objectives. Using appropriate methods and a flexible interpersonal style to help with the completion of team goals.
  • Customer Focus. Making customers and their needs a primary focus of one’s actions; developing and sustaining productive customer relationships. Passionate about service delivery and meeting the demands of the customer.
  • Planning and Organizing. Establishing courses of action for self and others (where appropriate) to ensure work is completed efficiently.
  • Brand Values. Embraces and supports the Company’s brand values of Performance, Innovation & Trust.

SCOPE

Budget:
Manage time for project and initiative budgets where responsibility relates to oversight/delivery
Supervision:
Champion ideas and accept disagreement with maturity and with the good of the business at heart.
Internal Relationships:
  • Work and partner with IT and Business leaders and project team members, 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.
External Relationships:
Work and partner with software vendors and SaaS suppliers when necessary.
Organization Influence:
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.
Limits of Authority:
The individual is responsible for IT compliance requirements. The Manager of Global compliance within IT Governance is responsible for the overall actions of this position.

PHYSICAL DEMANDS

The position requires the ability to:

  • Work in an office with a high degree of PC work and meeting attendance.
  • Travel as described above.
  • Apply Online