Sr Analyst, Digital Core
Johnson & Johnson
12 days ago
Remote friendly (Raritan, NJ)
United States
IT
Sr Analyst, Digital Core (Bangalore, India)
Key Responsibilities
- Ensure early EQ involvement in application/infrastructure design/development so automated and preventive controls are built in.
- Own and lead end-to-end quality process/strategy; provide compliance guidance for applications and support infrastructure.
- Provide strategic direction and operational support; manage execution of TQ tasks to meet plans, goals, and timelines.
- Develop and contribute to qualification/validation strategies for new and emerging technologies.
- Maintain inspection readiness; participate in audits; approve non-conformity action plans and closures.
- Support incident management, CAPA, and non-conformance resolution for in-scope systems.
- Review/approve validation work and sign off on releases to production (e.g., compliance plans, UR/US, system tests, UAT, traceability matrices, compliance reports).
- Monitor alignment to SOPs/industry guidelines; collaborate on costs, schedules, resources, and quality.
- Partner cross-functionally to implement compliant solutions and communicate quality risks.
- Lead/mentor people; apply risk-based validation; manage consultants/vendors.
Education (Required)
- Bachelor’s (or equivalent) in CS, IS, Business Admin, Science, Engineering, or related field.
Required
- 2–4 years in pharma/med device/biotech with direct Computerized System Validation experience.
- Independent quality/validation task management; solutions-oriented, risk-based compliance.
- cGMP/CSV knowledge incl. 21 CFR Part 11, 210, 211, 820.
- Experience with qTest, Jira (Xray), Identity & Access Management; OT security tools.
- CI/CD tools: Jenkins, GitHub, Bitbucket, Artifactory.
- Cloud software quality experience (VPCx, cloud storage/compute, Kubernetes, Chef, etc.).
Preferred
- Quality management system implementation; cybersecurity/privacy awareness; security role/SoD best practices.
- Audit/inspection readiness; digitization of validation processes.
- SDLC quality management + CSV/CSA; global regulations (EU Annex 11, SOX, HCC, Security/Privacy, ISO), GAMP 5 and ITIL.
- Agile/SAFe/RPA/IoT/Data & Analytics/AI/Intelligent Automation/Blockchain.
Other
- Proficient English (written/oral).
- Up to 10% domestic/international travel may be required.
Key Responsibilities
- Ensure early EQ involvement in application/infrastructure design/development so automated and preventive controls are built in.
- Own and lead end-to-end quality process/strategy; provide compliance guidance for applications and support infrastructure.
- Provide strategic direction and operational support; manage execution of TQ tasks to meet plans, goals, and timelines.
- Develop and contribute to qualification/validation strategies for new and emerging technologies.
- Maintain inspection readiness; participate in audits; approve non-conformity action plans and closures.
- Support incident management, CAPA, and non-conformance resolution for in-scope systems.
- Review/approve validation work and sign off on releases to production (e.g., compliance plans, UR/US, system tests, UAT, traceability matrices, compliance reports).
- Monitor alignment to SOPs/industry guidelines; collaborate on costs, schedules, resources, and quality.
- Partner cross-functionally to implement compliant solutions and communicate quality risks.
- Lead/mentor people; apply risk-based validation; manage consultants/vendors.
Education (Required)
- Bachelor’s (or equivalent) in CS, IS, Business Admin, Science, Engineering, or related field.
Required
- 2–4 years in pharma/med device/biotech with direct Computerized System Validation experience.
- Independent quality/validation task management; solutions-oriented, risk-based compliance.
- cGMP/CSV knowledge incl. 21 CFR Part 11, 210, 211, 820.
- Experience with qTest, Jira (Xray), Identity & Access Management; OT security tools.
- CI/CD tools: Jenkins, GitHub, Bitbucket, Artifactory.
- Cloud software quality experience (VPCx, cloud storage/compute, Kubernetes, Chef, etc.).
Preferred
- Quality management system implementation; cybersecurity/privacy awareness; security role/SoD best practices.
- Audit/inspection readiness; digitization of validation processes.
- SDLC quality management + CSV/CSA; global regulations (EU Annex 11, SOX, HCC, Security/Privacy, ISO), GAMP 5 and ITIL.
- Agile/SAFe/RPA/IoT/Data & Analytics/AI/Intelligent Automation/Blockchain.
Other
- Proficient English (written/oral).
- Up to 10% domestic/international travel may be required.