Lead, Complaints​/Adverse Events

• Ensure that all J&J quality standards and global regulatory requirements are met

• Own the quality approach for systems and hold teams accountable for delivering an end-to-end support model

• Collaborate with globally diverse teams in an inclusive environment

• Provide technical and procedural expertise/guidance to project teams, aligning with internal and external stakeholders

• Plan, allocate tasks and resources, execute, coordinate, and maintain validation activities for GxP systems/applications

• 6+ years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required
• Experience managing and leading global technology programs along with FTEs/consultant teams across multiple geographies
• Strong skills in interdependent partnering and influencing
• Superior written and oral communication skills
• Demonstrated leadership capabilities fostering diversity and inclusion
• Bachelor's degree in computer science, Information Systems, Business Administration or another related field required.
• Proficiency using JIRA, Qtest, Xray, Jenkins, Selenium is highly desirable
• Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is required