IT Quality/Validation Specialist — Roche

Descrizione completa

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 Role Description & Mission Experience Required -7 to 14 years As an IT Quality/Validation Specialist in RDT / Pharma R&D, you will independently manage end-to-end quality and analysis tasks across various capabilities. You will provide expertise, guidance, and coaching as a subject matter expert to relevant stakeholders and RDT colleagues to ensure best practices are practically and pragmatically applied. Acting as a trusted advisor, you will lead the analysis of moderately complex business problems, define problem scopes, drive root cause analysis, and translate requirements into strategic implementation plans that align with overarching business objectives. What You’ll Be Working On (Job Responsibilities)

• Validation & Compliance: Stay up to date on relevant industry guidance & regulations relating to Computer Software Validation and Assurance (such as, but not limited to: AAMI: TIR45 (2012), 21 CFR Part 11, and Annex 11). Support periodic reviews and implementation of CSV policies, ensure inspection readiness, and provide support during audits.
• Scope & Content Leadership: Independently manage end-to-end quality analysis tasks across various capabilities, mentor more junior team members, and contribute to the development of Quality Specialist best practices.
• Risk-Based Quality Assurance: Partner with relevant stakeholders to ensure that control artefacts relating to IT technical product development, maintenance, and deployment processes are "right-sized" based on the risk profile of the system.
• Accountability & Problem Solving: Independently lead the analysis of moderately complex business problems, driving root cause analysis and synthesizing complex stakeholder needs. Apply advanced analytical and logical reasoning to proactively identify discrepancies, evaluate change scope, and drive process improvement initiatives.
• Agile & CSV Validation: As an active part of CSV and Agile validation processes, you will be working on reviews and approvals of documents and changes. Provide advice, guidance, and coaching to squads on the appropriate application of supporting tools (such as JIRA, HP ALM, Retina, Trello, Service Now, etc.) to meet Computer Systems Validation and Assurance needs.
• Stakeholder Management: Identify a diverse range of stakeholders across functional areas, analyzing their influence and impact on project outcomes. Collaborate with cross-functional teams including Business Quality to ensure compliance with corporate policies regarding computer software assurance and alignment across the network.
• Impact, Strategy & Complexity: Manage quality analysis activities on more complex projects or across multiple products within a domain. Translate requirements into strategic implementation plans, evaluate solution options (including cost-benefit analysis), and develop comprehensive stakeholder maps. The Ideal Candidate (Qualifications & Experience)
• Experience: Experience independently managing end-to-end quality analysis tasks across various capabilities and driving root cause analysis. Must be passionate about compliance and able to inspire others.
• Validation Expertise: Exhibits the behaviors and understanding of computer system assurance/validation. Enables speed where speed is appropriate and control where control is necessary by applying a deep understanding of risk-based validation/assurance approaches.
• Methodology: Passionate about critical thinking, risk-based problem-solving, and Agile/SCRUM methodology.
• Te