Work with project stakeholders and Validation Managers to support regulated non-product software Validation Plans defining the approach to perform the required validation activities, the list of deliverables, acceptance criteria and support processes required
Provide guidance on validation approach for validation project team
Participate in supplier qualification of regulated non-product software to determine Supplier Risk and disposition the supplier’s adequacy
Evaluate the results of the assessment including mitigation of identified issues to propose to VM regulated non-product software validation approach and deliverables
Review and approve validation deliverables as required by Client QMS, regulatory compliance and any specific validation plan requirement
Support change control process from Assess change control validation impact through closure including approval and authorization for move into production
Work with the IT Validation Team and IT Management to ensure validation demand is prioritized and acted upon in the most efficient way possible, without compromising compliance or quality
Communicates solutions, validation status with cross functional partner organizations
Your skills
Minimum 5 years’ experience in Information Technology and Risk & Compliance but typically 7+ years
Experience working with virtual teams on a global basis
Strong communication skills in English
Quality minded – must be focused on, and capable of, delivering high quality validation related contributions to the Client IT function
Inclusiveness – demonstrated ability to work well within an IT Validation Team and with people at all levels of the Client and broader Danaher organization
Influencing/communication - Excellent influencing, interpersonal and communications skills (both written and verbal) with all levels of an organization
Logical thinking – can deal with ambiguity effectively in order to create logical, structured and credible validation plans/strategies
Pragmatism/creativity – Is passionate about validation and the value it brings / role it plays in IT and is able to think creatively and pragmatically in order to ensure that value is applied in the most effective way