Manager

• Ensure that all J&J quality standards and global regulatory requirements are being met
• Ensure that building and execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible
• Own the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope
• Provide technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders
• Plan, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications
• Support internal audits and Health Authority regulatory inspections
• Responsible for the approval of SDLC validation documentation deliverables including the approval to release system implementation and/or changes for production use
• Attend project team meetings and provide EQ compliance guidance and support to project and base business support team members
• Lead globally diverse teams in an inclusive environment
• Provide an environment which encourages the company’s credo and the value of a diverse workforce
• Serve as a trusted partner across the Enterprise Quality organization, requiring strong collaboration skills at the senior leadership level, and includes making recommendations for improvements relevant to senior level stakeholders

Enterprise Quality R&D Clinical CSV Manager

Enterprise Quality R&D Clinical Computer System Validation Manager

Manager, RA Submissions

Senior Manager, RA Submissions