Senior Validation Manager

Roles & Responsibilities:

• Prior JNJ TQ Experience a must
• Experience in validating QMS and different modules in QMS
• 5+ years' experience with System Development Lifecyle 10+ years' experience in Computer System Validation (Based on the role selected)
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Experience with QMS, including giving guidance when a Non-Conformance has occurred on a system.
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance Plans, test protocols, Test Summary reports and Compliance Reports
• Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
• Preferred tools knowledge and experience: JIRA, qTest, Service Now, XRAY and Change Record review
• Technology Quality representative and provide quality guidance from a CSV perspective based on the Pharmaceutical CSV Framework and SDLC process Strong verbal and written communication skills.
• Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management.