Specialist IS Business Analyst
Amgen (company site, opens in a new tab)8+ yrsHyderabadOn-siteDirect career pageEst. 18–30 LPA
Posted on 15 Sept
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Job description
Structured overview of role & requirements
About This Role
- Lead validation strategy and governance for GxP-regulated applications, ensuring compliance with SOPs, regulations, and industry standards.
- Own end-to-end validation activities including authoring validation deliverables and managing RTM traceability to ensure inspection readiness and audit support.
- Lead and mentor a validation team, partnering cross-functionally to drive compliant, timely delivery and continuous improvement initiatives.
Minimum Requirements
- Bachelor's or Master's degree in Computer Science, Engineering, Information Systems, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field.
- 8+ years experience in Computer System Validation (CSV), Quality Assurance, or GxP-regulated environments.
- 3+ years experience leading validation teams, programs, or quality compliance initiatives.
- Strong knowledge of GxP regulations, FDA 21 CFR Part 11, Annex 11, and Data Integrity requirements.
Ideal Candidate Profile
- Experienced in leading validation of global, enterprise-scale digital platforms in regulated environments.
- Demonstrated ability to manage full validation lifecycle including risk-based strategies, compliance documentation, and traceability matrices.
- Skilled at collaborating with Product, Business, Quality, Regulatory, and Technology stakeholders to deliver quality-driven solutions under inspection-ready conditions.