Senior Analyst, Digital Core

Johnson & Johnson

Sr Analyst, Digital Core at Johnson & Johnson enhancing healthcare solutions through quality assurance. Collaborate on application development and validation ensuring compliance with global regulations.

Posted 5/25/2026full-timeRemote • 🇮🇳 IndiaSeniorWebsite

ATS Keywords

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Hard Skills

Computerized System ValidationcGMP regulations21 CFR Part 1121 CFR Part 21021 CFR Part 21121 CFR Part 820risk-based validationvalidation strategiesincident managementCAPA

Soft Skills

solutions orientedself-managementindependencepragmatic advisingleadershipmentoringcommunicationcollaborationquality guidanceresource management

Tools & Technologies

qTestJiraXrayIdentity and Access ManagementOT security toolsJenkinsGitHubBitbucketArtifactorySOPs

Industry Keywords

pharmaceuticalmedical devicebiotechquality processvalidation activitiesinspection readinessauditsnon-conformityproject managementemerging technologies

Tech Stack

Tools & technologies

Jenkins

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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
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 Management and OT security tools
Experience working in a fast paced CICD environment with tools like Jenkins, GitHub, Bitbucket and Artifactory
Proficiency in the English language, both written and oral, is required.

Benefits

Comp & perks

Inclusive work environment
Health insurance
Professional development opportunities