Job Summary

Serve as the accountable owner of one or more GxP-regulated business systems throughout their entire lifecycle - from initial validation through adoption, evolution, and decommission - ensuring each system is fit for purpose,ms compliant, and delivering measurable value to GSK.

Key Responsibilities

- Strategic System Ownership: Maintain a deep understanding of the business processes your system supports. Map system roadmap priorities to business outcomes and proactively identify when a system should be invested in, fixed, consolidated, or decommissioned.
- Release Change Management: Own end-to-end release readiness: coordinate change control, manage validation evidence packaging, run stabilisation reviews post-release, and track release quality metrics. Minimise business disruption through predictable, well-communicated releases.
- Validation Compliance: Execute and maintain validation activities in accordance with DTMS and applicable regulatory standards (21 CFR Part 11, EU GMP Annex 11). Ensure PCRs, CAPAs, and access reviews are completed on time. Operate an assurance-first validation approach to reduce effort and calendar time without compromising compliance posture.
- Adoption User Experience: Drive measurable user adoption: develop training materials, coordinate change communications, monitor adoption curves, and act on System Usability Scale (SUS) data and user feedback to continuously improve the user experience.
- Support Continuous Improvement: Monitor and act on support signals - help desk data, repeat issues, Tier 1 resolution rates - converting them into roadmap improvements and stakeholder communications. Target measurable reductions in support friction over time.
- Portfolio Scorecard Reporting: Own your systems scorecard in Flight Deck: maintain current lifecycle phase, health RAG, top risks, and decisions needed. Contribute to the monthly ISS LT performance pack and quarterly system landscape reviews with decision-ready insight.




- Stakeholder Engagement Governance: Serve as the primary point of contact for your assigned business system(s). Build and maintain effective relationships with business owners, GPOs, QA, IT, and vendor partners. Represent system needs and priorities in governance forums.
- Resource Capacity Visibility: Track effort by system and work type to support ISSs capacity model. Proactively flag capacity constraints and contribute to quarterly prioritisation and trade-off discussions.
- BSO Community Mentorship: Participate actively in the BSO community of practice. Share best practices, contribute to playbook development, and support the onboarding and development of less experienced BSOs.

Education Requirements

- Bachelors degree or equivalent; scientific, technical, or business discipline preferred.
- Masters degree or equivalent experience advantageous.

Job Related Experience

Essential Experience

- Experience in pharmaceutical, life sciences, or equivalent regulated industry.
- Demonstrated experience with GxP system validation (DTMS, GAMP 5, or equivalent).
- Track record of managing systems, projects, or products through full lifecycle.
- Ability to translate business requirements into technical and process solutions.
- Robust stakeholder management across cross-functional, global teams.

Preferred Experience

- Experience operating KPI/OKR frameworks or scorecard-driven management systems.
- Familiarity with 21 CFR Part 11, EU GMP Annex 11, ICH, or FDA data integrity requirements.
- Exposure to system decommissioning, portfolio simplification, or vendor management.
- Experience with helpdesk/support analytics and usability assessment (e.g. SUS).

Skills

- Change Controls
- Compliance Management
- Computer System Validation (CSV)
- Requirements Gathering
- Veeva

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Technical Analyst (Bengaluru)
🏢 GSK India
📍 Bengaluru