Roche
Healthcare
ITQualitySpecialistRDTDIAR&D
“IT Quality Specialist - RDT DIA R&D at Roche. Skills: Computerized System Validation, GxP, Agile, Quality. Coordinate global validation activities. Author and review CSV deliverables”
What You'll Achieve.
Prevent, stop and cure diseases; Ensure everyone has access to healthcare; Power Roche through cutting-edge digital technologies; Shape tomorrow’s digital future of healthcare; Enable smarter ways of working; Unlock human potential; Drive breakthroughs that truly matter for millions of patients
Industry & Context.
Problem Solving; Apply a 'lean and innovative' mindset; Complex validation challenges; Navigate ambiguous requirements; Interdependencies across large-scale, complex products
Hybrid work model, In offices on average two days per week, Flex Location (possibility to perform our work from different places in the world for a certain period of time)
What They're Looking For.
Must Have
10+ years in CSV (COTS & custom software), GxP environments, Expert in FDA/EU GxP, 21 CFR Part 11 (ERES), PIC/S, EU Annex 11, GAMP 5, TIR045, Data Integrity (MHRA/FDA), Authoring/reviewing VP/VR, Authoring/reviewing TP/TR, Authoring/reviewing URS, Authoring/reviewing FRS, Authoring/reviewing SRA/FRA, Authoring/reviewing SAT, Authoring/reviewing UAT, Authoring/reviewing TM, Proficient in IRM (Security/Privacy/Regulatory), Diverse testing types (exploratory, regression, unscripted), SDLC/Agile (Scrum/SAFe), Requirements/data analysis, Evaluating solution impacts, PDP for Medical Devices, Experience with global teams, Fluent English, Mentoring junior staff, Driving process improvements
Nice to Have
Computerized System Validation, Quality processes, Information Security Coordinator (ISC), System Compliance Maturity Dashboard, Organizational best practices, Communities of Practice (CoPs), Regulatory alignment, Product squads, Lean and innovative mindset, Complex validation challenges, Ambiguous requirements, Interdependencies across large-scale, complex products
What You'll Do.
Coordinate global validation activities
Author and review CSV deliverables
Act as Information Security Coordinator
Act as CSV subject matter expert
Lead periodic reviews
Ensure audit readiness
Manage System Compliance Maturity Dashboard
Assess system changes
Contribute to organizational best practices
Partner with Quality departments
Ensure regulatory alignment
Apply lean and innovative mindset
Manage data usability
Manage process analysis
How You'll Work.
Team & Collaboration
Part of global teams; Partner with Quality departments; Act as a trusted advisor across multiple product squads; Facilitating workshops; Resolving conflicts; Experience with global teams
Communication Scope
Fluent English
Process & Methodology
Validation Leadership, Complexity Management
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