Lead, Complaints​/Adverse Events; CSV

Enterprise Quality Overview

Enterprise Quality (EQ) is a comprehensive organization within J&J focused on ensuring the highest standards of quality & compliance across the Innovative Medicine and Med Tech segments. EQ manages Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, while leading strategic initiatives such as data strategy, automated product release, and digitalization of Quality Management Systems.

• Ensure all J&J quality standards and global regulatory requirements are met.
• Integrate early quality involvement in design and development, embedding quality controls within applications and solutions, and leveraging automation when feasible.
• Own the quality approach for systems and hold teams accountable for an end‑to‑end support model.
• Provide technical and procedural expertise 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.

• Ensure early involvement of EQ in the design and development of applications and infrastructure.
• Own and manage the end‑to‑end quality process and strategies for building and execution of applications and supporting infrastructure.
• Ensure that all Quality Operations related projects go through the Intake process.
• Provide strategic direction and operational support to the individual project teams.
• Contribute to the creation of strategies for the qualification and validation of new and emerging technologies.
• Provide compliance guidance and support to the project teams to ensure successful delivery of the project end‑to‑end.
• Ensure a high degree of inspection readiness in support of health authority inspections, audits, and periodic review.
• Participate in audits, approve audit non‑conformity action plans, and approve closure of internal audit findings.
• Assist with incident management/CAPA and NC for the systems supported.
• Manage the execution of technology quality tasks according to the project plan, goals, and timelines.
• Support the allocation of resources by accurately communicating availability.
• Review and approve validation deliverables, such as compliance plans, user requirements, system tests, user acceptance tests, traceability matrices, and compliance reports, including final release and approval for production use.
• Proactively monitor systems and processes to ensure compliance with standard operating procedures and industry best practices.
• Work with manager in developing, monitoring, and managing project costs, schedules, resources, and quality of work product.
• Assist or drive status meetings to communicate and address project risks or issues.
• Work collaboratively with project teams to keep them informed of project status, including any barriers.

• Partner with project teams to assess and implement compliant solutions to meet their business needs.
• Build and maintain trusting, collaborative relationships and partnerships with internal and external stakeholders.
• Provide partnership, insight, and direction to cross‑functional business leaders and stakeholders regarding EQ policies, solutions, and initiatives.
• Communicate proactively with stakeholders to set expectations on the feasibility and timeframe for the delivery of solutions and highlight the risk when quality standards are not met.

• Provide quality guidance and support to project and/or base business support…