IT Quality Specialist - Pharma R&D

Roche; Hyderabad; On-site; INR 1,500,000 - 2,700,000; Full time

Job summary

Roche is seeking an IT Quality Specialist to independently manage end-to-end quality and analysis tasks across capabilities. You will lead stakeholder analysis, drive root cause analysis, and ensure comprehensive requirements traceability for large-scale initiatives.

You will mentor junior members, champion process improvements, and collaborate with Global Privacy, IT Security, and Business Quality teams to adhere to GDPR, HIPAA, 21 CFR Part 11, and ISO 13485 standards.

Qualifications

• Experience in IT quality assurance within pharma/biotech domains.
• Knowledge of regulatory standards (GDPR, HIPAA, 21 CFR Part 11, ISO 13485) required.
• Ability to translate business needs into validated IT solutions.
• Strong communication and mentoring skills.

Responsibilities

• Collaborate with cross-functional teams to define scope, constraints, and risks.
• Manage compliance documentation and traceability artifacts.
• Create and maintain Risk Assessments, Validation Plans, and Traceability Matrices.
• Configure systems and advise on enhancements and new implementations.
• Lead UAT planning and execution.
• Partner with Global Privacy, IT Security, and Business Quality teams to ensure governance standards.
• Drive AI-assisted quality control and data validation across platforms.

Skills

IT quality assurance

GxP/CSV knowledge

Agile and Waterfall

Stakeholder management

Education

BA/BS in life science, informatics, or business

Tools

AI-powered analytics tools

Validation/QA tools

Job description

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
  • User Requirements and Functional/Technical Specifications
  • Validation Plans, Reports, and Registries
  • Requirements Traceability Matrices, Test Plans, and Test Reports
  • 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

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.

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Who we are

A healthier future drives us to innovate. Together, more than 100’000 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.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.