Senior Manager – Security, Data and Digital Core

Responsibilities

• Building and Execution of Quality into Applications and Supporting Digital Core
• Ensures/promotes early involvement of TQ in the design and development of applications and infrastructure to ensure automated and preventive controls are built in
• Manages the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure
• Ensure that all Tech Quality related projects go through the Intake process
• Provides strategic direction and operational support to the individual project teams
• Supports the building and execution of quality into Strategic Programs across the enterprise where the use of technology supported by TQ is involved
• Partners with ISRM on various initiatives and innovation programs across J&J globally serving in a quality strategy advisory capacity in the development of compliant pathways that meet regulatory requirements.
• 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
• Applies expert knowledge of regulations, technology, and risk control frameworks to develop and evolve tailored Quality Management System processes and approaches for security requirements.
• 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 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 TQ tasks according to project plans, 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
• Tracks and documents quantifiable business results achieved from project work and writes success stories for publication that demonstrate the business value created by TQ
• Manages Project budgets
• Collaborate with Data & Digital Strategy team to support execution of Data & Digital Strategy roadmap data integration, governance and emerging data needs
• Partners with Quality Management Systems team to execute defined strategies and provide input and feedback on the efficacy of the strategy, including any recommendations for improvements
• Partners across the organization to train and implement new strategies for improvements
• Maintains a relationship with the segment Quality Organizations for ensuring handoffs (platforms vs application) , R&R's on Data and Platforms systems
• Partners with Technology Regulatory Compliance to ensure compliance requirements are embedded into Quality Strategies
• Partners with ISRM, JJT-Technology Services, Technology Quality, J&J Med Tech Quality, and JJT Innovative Medicine Quality organizations to sustain cybersecurity, data integrity, and compliance posture across regulated areas.
• Demonstrates an understanding of many relevant Quality and Compliance principles including Data Integrity, privacy, Cybersecurity and their applications
• Works collaboratively with project teams to keep them informed of project status, including any barrier
• Assists or drives status meetings to communicate and address project risks or issues
• Defines internal standards to move the organization toward a more positive risk management posture by utilizing extensive knowledge of current and emerging best practices in risk management
• Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
• Partners with stakeholders to assess and implement compliant solutions to meet their business need
• 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
• Gains alignment on funding and support of the project with the Business Sponsor and/or Investment Owner
• 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 risks when quality standards are not met
• Identifies critical skills and capabilities required to ensure the development of a highly skilled, high-performance team
• Provides quality guidance and support to project and/or base business support teams
• Utilizes…