Lead, Digital Core

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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Johnson & Johnson is currently recruiting for aLead Digital Coreto be locatedinRaritan NJ; Beerse Belgium; Mumbai IndiaandBangalore India.

About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-050032

India Requisition Number: R-050113

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Enterprise Quality (EQ) manages the Quality and Compliance strategy for IT systems including applications infrastructure and digital health solutions for J&J. EQ is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with J&Js 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.

Key Responsibilities:

• 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 healthauthority inspections internal/external audits and periodic reviews; participate in audits and approve nonconformity action plans and closures.
• Support incident management CAPA and nonconformance 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 crossfunctional team members to implement compliant solutions set expectations communicate feasibility/timeframes and highlight quality risks.
• Lead and mentor people: provide quality guidance apply riskbased 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.

Education

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

Experience and Skills

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.

Preferred:

• 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.

Other:

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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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