Senior Manager – Security, Data and Digital Core

Jobtailor; New Jersey; On-site; USD 130,000 - 170,000; Full time

Job summary

Jobtailor is seeking an experienced Quality Compliance and Validation leader to drive end-to-end quality management across applications and infrastructure in the pharmaceutical/medical device space.

You will lead cross-functional teams, ensure regulatory compliance, and maintain inspection readiness through robust validation programs and risk-based approaches.

Qualifications

• Bachelor's degree in Computer Science, Information Systems, Business Admin or related field.
• 8–10 years in pharma/medical device/biotech with computerized system validation.
• Experience running end-to-end validation programs (LIMS, CAPA, MES, PLM, SAP, LMS).
• Experience authoring validation protocols and related documents.

Responsibilities

• Build and execute quality into applications and infrastructure.
• Manage end-to-end quality processes and strategies for applications and infra.
• Ensure intake of all TQ projects and provide strategic direction.
• Collaborate with ISRM and Quality orgs to embed compliance and cybersecurity.
• Lead audits, CAPA, NC closure, and inspection readiness activities.
• Mentor teams and train staff on QMS, data integrity, and regulatory expectations.

Skills

Quality mgmt systems

Cross-functional leadership

Risk management

Regulatory compliance

Inspection readiness

Mentoring & training

Education

Bachelor's degree in CS/IS/related field

Tools

LIMS

CAPA

MES

PLM

SAP

LMS

Job description

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 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 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

Requirements

• 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

Core Competencies

Demonstrates expertise in Quality Management Systems, Computerized System Validation, and regulatory compliance within the pharmaceutical and medical device industries. Proven ability to lead cross-functional teams, manage end-to-end quality processes, and ensure inspection readiness.