IT Quality Specialist - Pharma R&D

Overview

Independently manage end-to-end quality and analysis tasks across IT capabilities, lead stakeholder needs analysis and root cause analysis, and ensure requirements traceability across large-scale initiatives.

What you'll do

• Collaborate with cross-functional teams, including Product Managers, Architects, Engineers, and UX Designers, to define scope, solutions, constraints, and project risks.
• Manage compliance documentation processes and systems, characterizing business solutions for compliance with internal and external regulations.
• Create and maintain System Risk Assessments and Data Classification Reports.
• Create and maintain User Requirements and Functional/Technical Specifications.
• Create and maintain Validation Plans, Reports, and Registries.
• Create and maintain Requirements Traceability Matrices, Test Plans, and Test Reports.
• Create and maintain Data/Process flow diagrams and training documentation.
• Configure system settings and provide consultation to customers regarding solution enhancements and new implementations.
• Facilitate UAT planning and execution.
• Serve as a trusted partner for Global Privacy, IT Security, and Business Quality teams, maintaining expert-level knowledge of governance standards (e.g., GDPR, CCPA, HIPAA, 21 CFR Part 11, ISO 13485).
• Drive the resolution of business or systems issues throughout the project lifecycle.
• Enhance the creation and maintenance of compliance documentation (e.g., System Risk Assessments, Validation Plans, Requirements Traceability Matrices) by leveraging AI-driven automation to reduce manual effort while maintaining compliance rigor.
• Implement AI-assisted quality control tools to automate data validation, anomaly detection, and cross-platform consistency checks, ensuring sustained data integrity and adherence to GxP/CSV standards at scale.
• Utilize AI-powered analytical tools to monitor platform performance, proactively identify process bottlenecks, and generate audit-ready compliance metrics.
• Guide the strategic deployment of AI agents within the IT Quality landscape, ensuring that AI-assisted workflows remain compliant by design and effectively support business requirements.
• Mentor junior team members and drive process improvements that align delivered solutions with overarching business goals.

What you'll need

• 7-10 years of related experience in an IT business systems analyst or IT quality assurance role.
• Strong domain knowledge of the pharmaceutical/biotech industry, manufacturing/quality assurance processes, and computer systems validation (CSV).
• Proven understanding of application development methodologies (Agile and Waterfall), including functional requirements, process modeling, and large-scale system implementations.
• BA/BS degree in life science, informatics, business, or equivalent.
• Excellent written and verbal communication, presentation, and facilitation skills.
• Demonstrated ability to build relationships, focus on the customer, and solve complex problems in fast-paced environments.
• Strong capability to independently apply tools, principles, concepts, and techniques related to requirements, data, usability, and process analysis.
• Ability to champion accountability by example, drive process improvement initiatives, and mentor junior team members.

Nice to have

• MA/MS or post-graduate coursework.

Details

• Location: Hyderabad.
• Shift: CET time zone.