• 15+ years of experience in managing quality and compliance across Software Development, Maintenance and Support for leading customers across Life Sciences, Insurance and BFS. • Proven record of track across Pharma GxP IT Compliance, Delivery Management, Test Management (STLC), Demand Management, Stakeholder Management, Scope and Change Management, Risk Management, Metrics-Based Management, Knowledge and Training Management, People and Performance management. • Deep understanding of industry regulations and guidelines such as GxP, 21 CFR Part 11 and GAMP 5. • Experienced in designing lean CSV solution to complement Agile, DevOps and Cloud transformations. • Expertise in guiding project teams to derive validation approach along with required validation deliverables across various methodologies/ principles like Waterfall, V model, Agile and DevOps. • Driven process improvements and innovations within the teams to bring in cost efficiency. • Strong commitment, accountability towards quality outcomes and excellent communication skills for articulating project needs to both teams and clients. • Pro-actively prioritize and track activities effectively to meet project commitments and schedules; consistently meets agreed timelines. • Have a brief onsite experience (USA) meeting business, IT and Quality stakeholders for fitment analysis. • Flexibility to adapt and excel client needs for project / practice purpose. • Possess good analytical, communication and leadership skills. Clifton Strengths: * Ideation * Achiever * Arranger * Developer * Restorative