Sr Analyst, Digital Core

Johnson & Johnson Innovative Medicine

1d•Remote

About The Position

Johnson & Johnson is currently recruiting for a Sr Analyst, Digital Core to be located in Bangalore, India. 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.

Requirements

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 Management 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

Nice To Haves

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.

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 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.