Sr. Validation Manager

  • Woodcliff Lake, NJ

Employment Type

: Full-Time


: Non-Executive Management

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This is a long term consulting opportunity with our direct client in Woodcliff Lake, NJ for a Sr. Validation Manager w/ a strong Pharma background. Senior Manager - Validation 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. Essential Functions Responsibilities Percent of Time 1. 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 70% 2. Provide expert CSV advice as necessary for the above three projects, to help ensure the validation will pass a health authority inspection 15% 3. 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. 15% Scope Measures Quantitative measures of impact: Numbers of validation documents reviewed and approved Number of change controls reviewed and approved Number of deadlines met 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 No travel required The position will require independent decision making for (but not limited to) the following: Acceptability of validation documentation including completed test scripts Providing solutions to unexpected developments - provided by Dice

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