Lead, Complaints / Adverse Events (CSV)

Job description

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 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 infrastructure in scope of the EQ portfolio Participates in audits, approves audit non-conformity action plans, and approves closure of internal audit findings Assists with incident management/CAPA and NC for the systems supported Manages the execution of technology quality tasks according to the project plan, goals and timelines Supports the allocation of resources by accurately communicating availability Responsible for managing resources (both internal and external) and ensuring availability for ongoing and upcoming initiatives/projects Reviews and approves validation deliverables, such as but not limited to Compliance Plans, User Requirements/User Stories, System Tests, User Acceptance Tests, Traceability Matrices, and Compliance Reports including final release and approval for production use Proactively monitors systems and processes to ensure compliance with standard operating procedures and industry best practices Works with manager in developing, monitoring and managing project costs, schedules, resources and quality of work product Assists or drives status meetings to communicate and address project risks or issues Works collaboratively with project teams to keep them informed of project status, including any barriers Stakeholder Management (20%) Partners with project teams to assess and implement compliant solutions to meet their business needs Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same Provides partnership, insight and direction to cross-functional business leaders and stakeholders regarding EQ policies, solutions, and initiatives Communicates 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 People Management (10%) Provides quality guidance and support to project and/or base business support teams Utilizes expert knowledge regarding risk management practices and leads and mentors the team with critical thinking and risk-based approaches to carry out validation of computerized systems and infrastructure Responsible for the management of consultants and outside service providers assigned to support EQ in project teams Works with EQ leadership to nurture future leaders and create opportunities to grow Mentors talent and helps them grow in their careers Performs other work-related duties as assigned Other Duties Develop and maintain an effective working partnership with senior management Collaborate with other leaders and staff within Enterprise Quality to ensure each function is executed in an efficient manner Ensure timely reports of status and metrics as required by the Enterprise Quality organization Ensure timely completion of assigned training and expense reports Required Qualifications Required Minimum Education: BS or Equivalent