Lead, Computer System Validation - T&DQ

Johnson Johnson; Raritan, Horsham (NJ, PA); In loco; USD 120.000 - 170.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson is seeking a Lead, Complaints / Adverse Events within Technology & Digital Quality. You will guide a team to ensure end-to-end quality across enterprise systems, applying CSV and validation practices in a global regulatory framework.

You will partner with diverse teams, drive quality initiatives, and promote the credo while maintaining inspection readiness and robust quality operations.

Competenze

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

Mansioni

• Own the end-to-end quality process for building and execution of applications and supporting infrastructure.
• Plan, allocate tasks and resources, execute, coordinate, and maintain validation activities for GxP systems/applications.
• Attend project team meetings, offering T&DQ quality and compliance guidance and support.
• Collaborate with globally diverse teams in an inclusive environment.

Conoscenze

Quality

CSV

GxP

Validation

Descrizione del lavoro

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

Technology & Digital Quality (T&DQ) 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.

Within Technology & Digital Quality, the IM Deployment office drives targeted strategic transformation and quality operations (CSV) initiatives aligned with the Innovative Medicine (IM) 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 T&DQ 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 Technology & Digital Quality organization, fostering strong collaboration skills at the project team level, internally and externally

Major Duties /Approximate Percentage of Time

Tasks/Duties/Responsibilities

70% - Building and Execution of Quality into Infrastructure

• Ensures/promotes early involvement of T&DQ 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 autho