Sr Mgr - Security, Data and Digital Core

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 management
• Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices

Stakeholder Management

• 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

People Management

• Manages and leads a globally diverse team across geographies, including FTEs and contractors, within a matrixed organization
• 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 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 development of direct/indirect reports including training and mentoring to meet current and future business needs
• Works with EQ leadership and pillar leaders to nurture future leaders and create opportunities to grow
• Mentors talent and helps them grow in their careers
• Guides and trains project and teams on QMS requirements, GxP data integrity controls, and regulatory expectations, ensuring inspection readiness.
• Conducts performance reviews, succession planning, talent reviews and career development for direct reports
• Provides an environment which encourages the company's credo and culture
• Ensures timely completion of assigned training and expense reporting

Education and Work Experience

• A Bachelor’s degree in Computer Science, Information Systems, Business Administration or another related field required; solid, relevant experience may be substituted when appropriate, additional certifications a plus
• 8-10 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required
• Experience in running 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

Required Skills:

Preferred Skills:

Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Tactical Thinking, Team Management