Sr Mgr - Security, Data and Digital Core

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: Quality Assurance Job Category: People Leader All Job Posting Locations: Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America Job Description: Technology Quality Operations (TQ) manages the Quality and Compliance strategy for Technology systems including applications, infrastructure and digital health solutions for J&J. TQ 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. Sr. Mgr TQ - Security, Data & Digital Core 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). 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 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 The role collaborates with business partners across Information Security Risk Management (ISRM) , J&J MedTech and J&J Innovative Medicine Quality organizations globally to sustain risk management and strong compliance posture in these areas This role will support internal audits and Health Authority regulatory inspections This role 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 EQ quality and compliance guidance and support to project and base business support team members This role will lead globally diverse teams in an inclusive environment This role will provide an environment which encourages the company’s credo and the value of a diverse workforce. This role serves as a trusted partner across the organization, requiring strong collaboration skills at the senior leadership level, and includes making recommendations for improvements relevant to senior level stakeholders Major Duties/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 MedTech Quality, and J&J 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 Project Management 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 Leads a team of external resources through the system lifecycle and utilizes expert knowledge regarding risk management practices Risk Management 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 managemen