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Tier-1 brand and remote role present, but specialized life‑sciences portfolio focus and seniority reduce competition.
Role requires life‑sciences regulatory, validation, and eQMS expertise, limiting cross-industry transferability.
Explicit 12+ years, mandated life‑sciences portfolio experience, regulatory validation and preferred certifications enforce strict filters.
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Lead and govern a portfolio of Quality and Compliance Systems programs across multiple business units, sites, and global regions focusing on life sciences sectors.
Define and execute portfolio strategy including roadmap, budgets, resource plans, and governance, ensuring delivery of digital quality transformation initiatives aligned with regulatory standards.
Manage end-to-end delivery of multiple complex quality system implementations and upgrades, maintaining compliance with regulations such as GxP, FDA 21 CFR Part 11, and ISO 13485.
Bachelor's degree in Life Sciences, Quality Management, IT, Engineering, Computer Science, or related discipline.
Minimum 12 years of experience in IT, Quality Systems, Digital Transformation, or Program Management with at least 5 years managing large-scale enterprise portfolios in Quality and Compliance Systems.
At least 5 years of experience in Pharmaceutical, Biotechnology, Medical Devices, or Life Sciences industry in regulated environments.
Work Experience Required: 12+ years; Location: Hyderabad, Telangana, India (Remote/Hybrid with travel as required).
Experienced in leading global, multi-site quality transformation programs within regulated life sciences sectors.
Skilled in managing cross-functional teams, stakeholders, vendors, and financials within complex portfolios involving electronic Quality Management Systems and related platforms.
Demonstrates strong knowledge of regulated system delivery, validation lifecycle, and compliance frameworks like CSV, CSA, GxP, and ALCOA+ principles.