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The Opportunity:
The Lead IT Expert involves creating test plans and protocols to evaluate system performance, analyzing system specifications using the latest tools to represent business and technical processes, and developing plans for system conversion and implementation. It also includes preparing and obtaining approval for system and programming documentation, recommending improvements in development, maintenance, and system standards, coordinating system upgrades, and assisting in training user personnel for system conversion and implementation. Additionally, the role may involve implementing company-wide, web-enabled solutions.
As the Lead IT Expert, you are responsible for:
Deliver value-based Quality Assurance strategies and roadmaps to support our Business and Foundation Domains
Determine validation approaches and identify deliverables needed or impacted by projects, enhancements, or changes for GxP computerized systems.
Verify testing plans, activities, deliverables, and records. Provide consultancy on test-related deviations and corrective actions as per approved procedures. Actively participate in CSV and Agile validation processes, authoring, reviewing, and approving documents and changes.
Cooperation with Business Line Leads on assessing and designing quality processes in Roche
Act as a subject matter expert in CSV for system audit/inspection preparation and execution. Ensure continuous inspection readiness and provide support during inspections and audits.
Driving technological development of Automation Testing area eg. creating a roadmap, recommending tools and solutions in test automation, introducing standards and work methodologies in the Quality Assurance area across Chapter.
Actively develops knowledge exchange forums and usage of new Quality Assurance methodologies and tools among SQA specialist
Co-designs development plans for employees aligned with the business strategy especially focusing on quality assurance and validation
Who You Are:
Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field with extensive knowledge of FDA regulations/guidance (e.g., CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices).
Minimum 8+ years of experience in IT & Software Validation (CSV/CSA, GAMP), Software Quality Assurance (Test management, Test Strategy and Test automation) with a proven track record of leading complex projects in the pharma environment including:
Leading validation or software testing for projects and system maintenance.
Authoring validation plans, reports, and deliverable registries.
Reviewing validation and testing-related deliverables, records, and other evidence, including relevant system documentation.
Supporting applications under global audit and inspection agencies.
Drive test automation adoption and implementation
Experience in building and implementing Quality Assurance Strategies, Test automation implementation for a enterprise-scale end-to-end programs
Broad experience in test management and test automation tools
Experience in working with EDMS (i.e Veeva) and with ALM Tools (like JIRA, RETINA or similar)
Comprehensive understanding of Agile Methodology (Frameworks such as SAFe, Scrum); extensive previous experience is highly desirable.
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.