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Tier-1 employer and Pune location increase competition, mitigated by niche ETQ/QMS regulatory specialization.
High: requires niche ETQ/QMS expertise and regulated medical-device compliance, limiting cross-industry transfer.
High: mandatory 8+ years, ETQ/QMS expertise, regulatory validation, and server/database skills.
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Design and implement enterprise Quality Management System (QMS) technical solutions and oversee all technical delivery for QMS platforms.
Define and enforce IT application standards aligned with global IT and industry best practices, manage platform roadmap, system updates, and security vulnerability resolution within SLAs.
Lead technical evolution and optimization of QMS, act as technical owner backup, handle Level 3 support, problem management, and change management in a global, matrixed IT environment.
Bachelor’s degree required.
8+ years hands-on experience designing, configuring, implementing, and maintaining enterprise quality management systems; experience with ETQ, IQVIA, or Force.com platform preferred.
Work Experience Required: 8+ years in relevant QMS design and implementation.
Experience in regulated environments with compliance knowledge (21 CFR part 820) is preferred but not mandatory.
Experienced in enterprise QMS architecture, particularly in pharmaceutical or medical device regulated settings.
Able to collaborate in a global, highly matrixed, team-oriented IT environment and present technical recommendations to senior leadership.
Skilled in managing vendor relationships, integration via APIs, server/client and web-hosted applications architecture, and working with validation deliverables within the SDLC for regulated applications.