IT Quality Specialist - RDT Biometrics and Clinical Evidence

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The Position

Job description

As an IT Quality Specialist, you independently manage end-to-end quality and analysis tasks across various capabilities and contribute to solving moderately complex business problems. You will lead the analysis of stakeholder 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.

Description of the area

This team is responsible for delivering software systems for the data acquisition and processing of Roche clinical trial data, serving as the source of truth across Roche Pharma. Foundational systems in this area include Roche’s electronic data capture (EDC) - Medidata Rave, non-CRF systems, and clinical data warehouses.

These systems are critical to drug development, powering clinical data review, safety reporting, operational insights for clinical teams, and support early development activities in the REDs. They provide data to the Analytical Data Science’s ecosystems to standardize and analyze data for regulatory submissions. In addition, standardized clinical data from these systems are essential to integrate with Roche’s specialized data modality platforms including omics, clinical imaging, and digital health technologies.

A key focus in this area will be to leverage emerging AI technologies to optimize clinical data acquisition data pipelines. This includes enriching metadata and building AI-ready datasets to enable autonomous agentic and human-in-the loop AI systems which are transforming the drug development process.

Job Responsibilities

• Scope / (Content Leadership): Independently manages end-to-end computer systems validation (CSV) and software quality tasks across various capabilities and contributes to more complex problems. Mentors more junior team members and contributes to the development of Quality Specialist best practices.
• Accountability/Problem Solving: Independently leads the analysis of moderately complex problems, clearly defining the problem scope and driving root cause analysis.
• Validation / Qualification Strategy: Determine computer systems validation (CSV) approaches and identify deliverables needed or impacted by projects, enhancements, or changes for GxP computerized systems.
• Approve Critical Validation Documentation: Review and approve essential lifecycle documentation such as Validation Master Plans, User Requirements, deviations, and Summary Reports in accordance with Roche CSV SOPs and regulatory guidance.
• Deviation and Root Cause Analysis: Support investigations into deviations, identifying root causes, and defining corrective and preventive actions.
• Audit and Inspection Readiness: Act as a subject matter expert in CSV for system audit/inspection preparation and execution.
• Drive Continuous Improvement: Partner with interdepartmental, multi-site, and global corporate teams to implement validation best practices and benchmark against industry standards
• Training and Knowledge Sharing: Provide training and exchange validation/quality knowledge and experience.

Qualifications

Education / Experience

• Bachelor's / Master’s degree in Computer Science, Information Technology, Life Sciences, or related technical field. Having professional certifications is an advantage.
• Minimum 5-8 Years of experience in Software and Systems Quality assurance
• Extensive experience in the validation of Computerized Systems in a GxP regulatory environment

Technical Skills

• Ability to handle and resolve complex quality issues using analytical and problem-solving skills.
• Strong understanding and application of GxP regulations and the regulations outlined in 21 CFR Part 11, EU Annex 11
• Follow SDLC and Agile methodologies (Scrum, Kanban, etc.), participate in requirements reviews and design discussions, document testing procedures and maintain test documentation, conduct reviews of test cases and test scripts, implement quality gates and exit criteria
• Advanced proficiency in tools like JIRA, ALM, Quality Systems, Test automation frameworks, API testing, etc.

Additional Qualifications

• Excellent verbal and written communication skills with a proven track record of working collaboratively in global cross-functional teams to achieve project milestones.
• Flexibility: Ability to adapt to shifting priorities and commit to collaboration with team members globally.

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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.