Lead, Complaints​/Adverse Events; CSV

Job Function

Quality

Customer/Commercial Quality

Professional

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

Enterprise Quality is a comprehensive organization within J&J that focuses on ensuring the highest standards of quality & compliance. It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation Operations and Temperature Control. Additionally, it includes a Transformation Office dedicated to steering strategic imperatives and enhancing the Quality & Compliance organization’s strategy through initiatives like Data Strategy, Automated Product Release, and Digitalization of Quality Management Systems.

The group further comprises a Data & Digital Strategy function tasked with developing and executing a holistic digital and data strategy to improve quality and compliance, covering areas such as Data Foundations, AI/ML & IoT technologies, Quality & Compliance Innovation, and Digital Assets validation. To facilitate the deployment of these strategic initiatives, the group employs two Deployment Offices for the Med Tech and Med Tech segments and maintains a global presence through three regional leaders managing operations in Asia Pacific (ASPAC), Europe, Middle East, Africa (EMEA), and the Americas.

Enterprise Quality (EQ) drives targeted strategic transformation and quality operations (CSV) initiatives aligned with the Innovative Medicine (IM) and Med Tech (MT) segment strategic priorities.

The Lead, Complaints / Adverse Events is responsible for guiding and managing the team throughout the building and execution of quality into enterprise wide systems, tools, services and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, retire).

• Ensure that all J&J quality standards and global regulatory requirements are met
• Ensure building and execution activities involve early quality involvement in design and development, integrating quality into work products, implementing controls within applications/solutions, and leveraging automation when feasible
• Own the quality approach for systems and hold teams accountable for delivering an end-to-end support model
• 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
• Support internal audits and Health Authority regulatory inspections
• Approve SDLC validation documentation deliverables, including release of system implementations/changes for production
• Attend project team meetings, offering EQ quality and compliance guidance and support
• Collaborate with globally diverse teams in an inclusive environment
• Promote an environment fostering the company’s credo and the value of a diverse workforce
• Serve as a trusted partner across the Enterprise Quality organization, fostering strong collaboration skills at the project team level, internally and externally

• Ensures/promotes early involvement of EQ in the design and development of applications and infrastructure to ensure automated and preventive controls are built in
• Owns and manages the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure
• Ensures that all Quality Operations related projects go through the Intake process
• Provides strategic direction and operational support to the individual project teams
• Contributes to the creation of strategies for the qualification and validation of new and emerging technologies
• Provides compliance guidance and support to the project teams to ensure successful delivery of the project end-to-end
• Ensures a high degree of inspection readiness in support of health authority inspections, audits (internal and external) and periodic review of applications and…