Validation Manager
Tech stack
risk analysis
Job description
What You’ll Do
- 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
Published: 16.10.2021
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