Product & Program Management | Computer System Validation | Quality Assurance | Audit & CAPA Management | GxP Application Testing | Stakeholder Management | Risk Management| Coaching & Mentoring | Training Management• Over 25 years of progressive experience in Life sciences (predominant), Aerospace, Banking & financial, Utilities, Manufacturing and HealthCare• Played various roles throughout the career like starting with developer, DB designer, Architect, Project Manager, Solution Manager, Program manager, CSV specialist, auditor & Compliance officer.• Practical experience in life sciences on computer system validation, monitoring IT controls, performing audits, program management, Test management for both GxP applications & non GxP programs. • Ability to drive strategic vision for QA organization to enable and promote quality & compliance within the organization. • Exceptional blend of technical, project management & CSV expertise with business acumen to align IT & Business and increase IT effectiveness through solution delivery and strong trust-based partnerships.• In-depth knowledge and experience of Life Sciences domain with program management, testing, Computer System Validation test automation, Computer System Validation (CSV), 21CFR Part 11, GxP, GAMP5, CAPA & Audit management• Strong understanding of GxP and regulatory requirements like 21 CFR Part 11, 21 CFR Part 820, that are essentials for IT application development and maintenance.• Proven track record of building, retaining and leading high-performing large global QA teams through mentorship, coaching, and training.• Experienced in setting up Audit-CAPA Management office to manage CSV activities