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 https://www.jnj.com

JOB DESCRIPTION:

Johnson & Johnson is currently recruiting for a Lead, Data & Platforms! This position can be located in Horsham, PA or Raritan, NJ.

POSITION SUMMARY:

Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with J&J’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections. The Lead of Data and Platforms, Technology Quality 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[1]to-end lifecycle (design, develop, implement, maintain, retire).

• This role must ensure that all J&J quality standards and global regulatory requirements are being met
• This role ensures that building and execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible • This individual will own the quality approach for systems and ensure teams are accountable for delivering on an end-to[1]end support model for systems in scope
• The role provides technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders
• The role is responsible for planning, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications
• This position will support internal audits and Health Authority regulatory inspections
• This position will be responsible for the approval of SDLC validation documentation deliverables including the approval to release system implementation and/or changes for production use, will attend project team meetings and provide TQ&C quality and compliance guidance and support to project and base business support team members
• This role will participate in globally diverse teams in an inclusive environment
• This role will participate in an environment which encourages the company’s credo and the value of a diverse workforce
• This role serves as a trusted partner across the Technology Quality & Compliance organization, requiring strong collaboration skills at the project team level, both internally and externally

EDUCATION:

A minimum of a Bachelors or equivalent University degree is required with a focus in Computer Science, Information Systems, Business Administration or another related field preferred.

REQUIRED KNOWLEDGE SKILLS & CAPABILITIES:

• 6+ years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required
• Experience in large scale end-to-end Validation programs like LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and Change Control is preferred
• Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is required
• Proficiency using the following tools is highly desirable: JIRA, HPALM, Xray, Jenkins, Selenium
• Experience managing and leading global technology programs along with FTEs/consultant teams across multiple geographies
• Direct experience working in a software development environment using Agile, SAFe, CI/CD or similar is desirable

KEY RESPONSIBILITIES:

Building and Execution of Quality into Applications and Supporting Infrastructure (70%)

• Ensures/promotes early involvement of TQ&C 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 Technology Quality 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 including AI/ML
• Keep up to date with the latest advancements in AI/ML technology and its regulatory requirements and apply them to improve the company’s offerings and compliance posture • 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 reviews of applications and infrastructure in scope of the TQ&C 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 TQ 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
• Performs reviews and approval of 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 the TQ Director 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

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 TQ&C 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 TQ in project teams
• Works with TQ&C leadership and pillar leaders to nurture future leaders and create opportunities to grow
• Mentors talent and helps them grow in their careers

Other Duties:

• Develop and maintain an effective working partnership with senior management
• Collaborate with other leaders and staff within Technology Quality and Compliance group to ensure each function is executed in an efficient manner
• Ensure adherence to the TQ&C Operating Model
• Ensure timely reports of status, metrics and time sheets as required by the Technology Quality and Compliance organization
• Ensure timely completion of assigned training and expense reports

Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with J&J’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections. The Lead of Data and Platforms, Technology Quality 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[1]to-end lifecycle (design, develop, implement, maintain, retire).

• This role must ensure that all J&J quality standards and global regulatory requirements are being met
• This role ensures that building and execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible • This individual will own the quality approach for systems and ensure teams are accountable for delivering on an end-to[1]end support model for systems in scope
• The role provides technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders
• The role is responsible for planning, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications
• This position will support internal audits and Health Authority regulatory inspections
• This position will be responsible for the approval of SDLC validation documentation deliverables including the approval to release system implementation and/or changes for production use, will attend project team meetings and provide TQ&C quality and compliance guidance and support to project and base business support team members
• This role will participate in globally diverse teams in an inclusive environment
• This role will participate in an environment which encourages the company’s credo and the value of a diverse workforce
• This role serves as a trusted partner across the Technology Quality & Compliance organization, requiring strong collaboration skills at the project team level, both internally and externall