Malini Gattu

About Malini Gattu

Experienced leader with extensive IT Pharmaceutical/Regulated industry experience leading strategic initiatives in Commercial, Clinical Development & Operations, Regulatory, Quality Assurance and GSE Initiatives. Hands on technology and management experience in designing, building and operating technology solutions to solve critical business needs across healthcare industry. Breadth of healthcare/ pharmaceutical experience leading multiple IT initiatives in major companies including Pfizer, Merck, Wyeth, AstraZeneca, Covance, Endo Pharma, Bristol Myers Squibb. Well recognized for technical expertise, IT Strategy, strategic quality planning and execution, exercising business acumen, leading cross functional global teams and consistently exceeding critical deadlines with customer focus approach.• Experienced in leading and contributing to Organizational success and value through a variety of roles as Technical Product Manager, Technical Delivery lead, Client Service Lead serving Merck and as Accenture Quality Assurance manager across big Life Science Clients in Northeast.• Led complex concurrent IT initiatives implementation with competing priorities in cross-functional global teams with substantial annual budget responsibility of $15M and product teams of 50+ professionals delivering substantial business value.• Consistent track record in executing large and complex projects in highly challenging and matrixed environments and worked on End-to-End project lifecycles, Agile Management, Digital and Service Delivery of COTS, SaaS, Custom developed and AWS applications.• Strong experience in 21 CFR Part 11 Regulations, Gxp and compliance Regulatory requirements for IT systems, Computer System Validation and Non-Gxp Systems across major life science clients. • Expertise in driving Business discovery and business process evaluation using User Requirement Analysis, Functional Specifications, Technical specifications, workflows, Use Cases, Business Rules, SIT/UAT Testing.• Proficient in Process Management, Project Management, SDLC, Quality Assurance, Computer System Validation (CSV)and Change, Incident, and Problem Management.

Experience

1. Global Development Veeva Quality IT Manager

   Regeneron

   Aug 2024 — Present

Education

• Osmania University, Hyderabad

  Master of Business Administration (MBA)

• St Francis Degree College

  Bachelor of Commerce(B. Com) (Honours)

Skills

• User Acceptance Testing
• Business Intelligence
• Test Management
• Integration
• Testing
• Business Analysis
• Offshore Management
• Software Development Life Cycle (Sdlc)
• Business Process
• Offshore Resource Management
• Agile Methodologies
• Regression Testing
• Cross-Functional Team Leadership
• Management
• IT Strategy
• Managed Care
• Sdlc
• Project Management
• Resource Management
• Etl Testing
• Requirements Analysis
• Informatics
• Software Project Management
• Extract, Transform, Load (Etl)
• Quality Center
• Pharmaceutical Industry
• Business Process Improvement
• Hp Quality Center
• Business Requirements
• Quality Assurance
• Test Planning
• Test Validation
• Healthcare
• System Testing
• Consulting
• Government Pricing
• Test Cases
• Functional Testing
• Medicaid