IT Quality Specialist - Pharmaceutical Research & Development

Roche Diagnostics India Pvt Ltd; Hyderabad; On-site; INR 1,400,000 - 2,000,000; Full time

Job summary

Roche Diagnostics India Pvt Ltd in Hyderabad is seeking an IT Quality Specialist to own end-to-end quality and analysis tasks across capabilities, driving root-cause analysis, requirements traceability, and governance alignment with GDPR, HIPAA, 21 CFR Part11, ISO13485.

You will mentor juniors, collaborate with Product Managers, Architects, Engineers and UX designers, and implement AI-assisted quality controls to enhance validation, data integrity and cross-platform consistency at scale.

Qualifications

• 7-10 years of experience in IT quality assurance or business systems analysis.
• Strong knowledge of CSV, GMP/GxP compliance, and validation practices.
• Bachelor's degree in life sciences, informatics, or related field.

Responsibilities

• Collaborate with cross-functional teams to define scope, solutions, constraints, and risks.
• Manage compliance documentation and systems for regulatory alignment.
• Create and maintain risk assessments, validation plans, and traceability matrices.
• Drive AI-assisted quality controls and data validation at scale.

Job description

IT Quality Specialist - Pharma R&D

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The IT Quality Specialist independently manages the end-to-end quality and analysis tasks across various capabilities and contributes to solving moderately complex business problems. You will lead the analysis of stakeholders needs, drive root cause analysis, and ensure comprehensive requirements traceability across large-scale initiatives. Acting as a trusted advisor, you will champion accountability, mentor junior team members, and drive process improvements that align delivered solutions with overarching business goals.

Key Responsibilities

• 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.
• Be accountable for the creation and maintenance of: System Risk Assessments and Data Classification Reports.
• Be accountable for the creation and maintenance of: User Requirements and Functional/Technical Specifications.
• Be accountable for the creation and maintenance of: Validation Plans, Reports, and Registries.
• Be accountable for the creation and maintenance of: Requirements Traceability Matrices, Test Plans, and Test Reports.
• Be accountable for the creation and maintenance of: 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 Part11, ISO13485).
• 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.

Experience Profile

• 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 (MA/MS or post-graduate coursework is a plus).
• 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.

Shift: CET time zone #Hyderabad2026

Who we are

A healthier future drives us to innovate. Together, more than 100000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Lets build a healthier future, together.

Roche is an Equal Opportunity Employer.

Experience Level Mid Level