Our client is looking for a Senior Manager - IT Quality Validation for their Woodcliff Lake, NJ headquarters.PLEASE NOTE: > Pharma experience is required - onsite roleThis Role Will Provide independent quality oversight via document review primarily for three high impact ongoing computer system validation (CSV) projects, as well as potentially for some minor ones. Ensure that the projects are completed on schedule (one as promised to health authorities). Essential Functions Review (and approve) computer system validation and related documentation generated for three essential ongoing projects for compliance with 21 CFR Part 11 and associated guidelines Provide expert CSV advice as necessary for the above three projects, to help ensure the validation will pass a health authority inspection Provide validation review and approval, and expert CSV advice, for other validation projects as well as for controlled changes to existing validated systems, as time allows. The position will require independent decision making for (but not limited to) acceptability of validation documentation including completed test scripts Providing solutions to unexpected developments Knowledge/Skills/Abilities Required Bachelor??s degree in associated functional discipline Experience with computer system validation projects, preferably in a clinical research environment, for at least 3 years Knowledge of 21 CFR Part 11, GAMP 5, and Annex 11 Quality Assurance experience, in addition to the above, preferred but not required Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task
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