Lead, Complaints / Adverse Events (CSV)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

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

Job Description:

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 MedTech and MedTech 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 MedTech (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

Tasks/Duties/Responsibilities (Approximate Percentage of Time)

Building and Execution of Quality into Infrastructure (70%)

• 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 executio