Aravindkumar Mahalingam Email & Phone Number

United States

Bridgewater, New Jersey, United States

Role Overview:At Saama, my primary mission as the Senior Director of Validation (QA) is to pioneer Quality Assurance program of the next-generation clinical development platform designed to expedite clinical trials.Achievements:Formulated a comprehensive QA strategy to Verify and Validate the Clinical platform and the products within the clinical platform few of which were AI/ML enabled. Conducted Training across teams. Write Testing , CSV SOPsEfficiency: Enabled QA efficiency measures in the overall QA outcomes, drastically improving the product quality , data integrity . Thought leadership in bringing the latest industry trends in QA like CSA approach , Automation , Critical thinking that eventually resulted in TTM (Time to Market) reduction.Process Leadership: Formulated unified & standardized process ( Testing) across various silo-ed products within SaamaTeam Building & Management: Established a scalable Test management function, assembling a team of skilled Technical & functional Testing SMEs and expeerts who are expert in the clinical domain.Skills: Life sciences & healthcare Domain · QA Leadership, Product Leadership · SaaS Development · Artificial Intelligence (AI) ·· Strategic Planning · Business Development · Team Leadership · Data hub · Operational Excellence · Clinical Data Management

Princeton, New Jersey, United States

Established Validation Center of Excellence (Val CoE) Practice in ZS. Spearheaded the creation of a Validation Strategy and Validation Plan for a CDR-SCE (Clinical Data Repository & Statistical Computing Environment) program. Led internal CSV Webinars at ZS to promote a comprehensive understanding of CSV concepts throughout the R&D team. Curated Quality Management System (QMS) package, complete with Standard Operating Procedures (SOPs) and Work Instructions, tailored for a Clinical Platform.• Presented a roadmap to ZS RDE leadership for the expansion of the Validation Center of Excellence team in 2021 & 2022, along with evaluating partner organizations.• Nurtured high-level executive partnerships and engaged in collaboration with essential client stakeholders to shape the Strategic roadmap for Computer System Validation.• Created Cut-over plan, Testing strategy (Data Migration, Integration testing) for study data migration from Legacy to Latest CDR-SCE ecosystem for one of ZS’s key Pharma client• Laid out a CSV to CSA roadmap for ZS Validation CoE.• Authored Testing and CSV SOPs for the Validation CoE.• Conducted Webinars and Training on CSV, Testing and Good Documentation Practices for Onshore and Offshore Teams.• Mentored Test Delivery Managers in IT methodology while actively fostering ongoing process improvement. • Created Validation assets for the ZS Validation team.

Bridgewater , Nj

Undertook diverse roles during an extensive tenure at Cognizant, ranging from Java/J2EE Developer to leading the QA organization for a clinical platform. Guided substantial QA teams both offshore (India) and onshore (US) while assuming the role of Test Delivery Program Manager. • Provided solutions for optimizing Testing engagement, transition methodology, and cost factors, incorporating industry Best Practices. • Defined and strategically implemented Change Management procedures to control and mitigate impact on predefined project scopes, business/application functionality, resource costs, and delivery timelines.• Instrumental in development and execution of key cut-over plans and processes.• Build & lead a global software quality assurance team- maturing processes, testing (including building automated software test framework), and performing internal audits.• Build & lead validation teams for client implementation projects, applying rigorous-yet-lean computer systems compliance approaches to meet changing industry thinking and standards (GAMP5, CSA, risk-based compliance).• Established and aligned a set of standardized and purposeful vision, goals, objectives, and metrics for QA Org, driving substantial enhancements in departmental performance.• Led Multiple Client Audits and represented the IT QA/QC team in answering Audit questions and presentations.• Conducted Webinars for QA teams on IT CSV, Validation & Verification• Managed teams responsible of SAP implementation testing and integrations.• Prepared Various Training materials on Testing, CSV processes, CSV to CSA roadmap approaches for the QA organization.• Successfully conducted multiple client product GxP audits, adhering to GAMP 5 guidelines, implementing Risk Based Testing (RBT), and conducting Functional Risk Assessments.• Conducted CAPA exercises for Bugs/ Audit findings.• Led QA program for medical device testing , devised V&V strategy , maintained DHF and conducted FMEA assessment

Chennai Area, India

- worked in GE Consumer product applications.- gained expertise in J2EE , EJB,VB,ASP,PL/SQL,Business Objects.

Bachelor Of Engineering ( B.E), Electronics & Communication Engineering

Activities and Societies: Amrita Alumini

10Th (Sslc), 12Th(Hsc) - Cbse