Lead, Digital Core

Johnson & Johnson-posted 5 days ago
Full-time • Mid Level
5,001-10,000 employees
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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. About MedTech Fueled by innovation at the intersection of biology and technology, we’re 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 https://www.jnj.com/medtech About 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 https://www.jnj.com/innovative-medicine Please 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&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.

  • 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.
  • Proficiency in the English language, both written and oral, is required
  • 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.
  • Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  • Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period10 days
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
  • For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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