Lead, Digital Core

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Johnson & Johnson is currently recruiting for a Lead, Digital Core to be located in Raritan, NJ, Beerse, Belgium; Mumbai, India and Bangalore, India .

• Ensure early EQ involvement in application and infrastructure design/development so automated and preventive controls are built in from the start.
• Own and lead the end-to-end quality process and strategy, providing compliance guidance for applications and supporting infrastructure.
• Provide strategic direction and operational support to project teams and manage execution of TQ tasks to meet project plans, goals and timelines.
• Develop and contribute to qualification and validation strategies for new and emerging technologies.
• Maintain inspection readiness for health authority inspections, internal/external audits and periodic reviews; participate in audits and approve non conformity action plans and closures.
• Support incident management, CAPA and non conformance resolution for systems in scope.
• Review and approve validation work and sign off on releases to production (Compliance Plans, User Requirements/User Stories, System Tests, UAT, Traceability Matrices, Compliance Reports, etc.).
• Proactively monitor systems and processes for alignment to SOPs and industry guidelines; collaborate with the EQ Manager to manage project costs, schedules, resources and quality.
• Partner with cross functional team members to implement compliant solutions, set expectations, communicate feasibility/timeframes, and highlight quality risks.
• Lead and mentor people: provide quality guidance, apply risk based validation approaches, manage consultants/vendors, nurture future leaders and ensure resource availability for initiatives.

This role builds and sustains a strong, collaborative partnership with senior management and works closely with leaders and staff across the EQ group to streamline functions and drive operational efficiency.

• Bachelor s or equivalent degree in Computer Science, Information Systems, Business Administration, Science, Engineering or another related field is required.

• 2-4 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities
• Ability to perform work with a high degree of independence in terms of self-management of a large variety of tasks and initiatives regarding quality and validation
• Solutions oriented, aiming for new ways to accomplish goals and pragmatic advising ensuring compliance in a cost-effective and risk-based manner
• Ability to manage multiple and competing projects
• Gives input and ensures adoption for how quality will be designed into/maintained and understands data integrity needed throughout the lifecycle within a technology solution
• Defines strategy for testing according to the risk assessment
• Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820
• Experience validating Testing Management tools like qTest, Jira with Xray and security tools such as Identity and Access Managment and OT security tools
• Experience working in a fast paced CICD environment with tools like Jenkins, GitHub, Bitbucket and Artifactory
• Experience working as Cloud software Quality - Virtual Private Clouds (VPCx), Cloud Storage and Computing, Containers services/Kubernetes, Chef etc.

• Implements elements of an effective quality management system to the organization and its technology solutions
• Aware of cybersecurity and privacy principles and implications for quality and risk management activities
• Applies best practices for security role design and segregation of duties within and across technology solutions
• Understands how to prepare an organization and business partners for audits and inspections
• Able to apply digitization tools and techniques to automate, simplify, digitize and enhance software development and validation processes
• Knowledge of SDLC Quality Management process and CSV/CSA principles
• Working knowledge of other Global Regulations like EU Annex 11, SOX, HCC, Security & Privacy, ISO
• Solid understanding of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
• Knowledge of the following technologies and methodologies is preferred: Agile, SAFe, RPA, IoT, Data & Analytics, AI, Intelligent Automation, Blockchain.

• Proficiency in the English language, both written and oral, is required
• Up to 10% travel both international and domestic may be required