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Sr Analyst, Digital Core
Job in
Raritan, Somerset County, New Jersey, 08869, USA
Listed on 2026-06-18
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-06-18
Job specializations:
-
IT/Tech
Data Analyst, Data Security, Cybersecurity
Job Description & How to Apply Below
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.
- Bachelor’s (or equivalent) in CS, IS, Business Admin, Science, Engineering, or related field.
- 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, Git Hub, Bitbucket, Artifactory. - Cloud software quality experience (VPCx, cloud storage/compute, Kubernetes, Chef, etc.).
- 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.
- Proficient English (written/oral).
- Up to 10% domestic/international travel may be required.
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