Quality & Compliance Specialist (CSV, GMP, GCP)

Overview

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.

What you’ll be working on

You will assure that Roche’s regulated / critical systems and services adhere to regulatory standards (CSV, GMP, GCP) and regulatory risks are managed adequately to protect Roche business. By providing automated control insights and streamlined monitoring capabilities, an effective and consistent tracking of Information on Quality Oversight is enabled. Governance and processes are provided to comply with GxP, Data privacy laws and regulations when processing and hosting Roche data.

Responsibilities

• Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV). Assemble global feedback on proposed or existing standards and tools and provide recommendations for new guidance / standards or revisions to existing guidance / standards. Provide consultation and guidance to delivery and operational units across Informatics on accurate interpretation of Roche CSV approach and requirements
• Provide independent Quality Assurance oversight / support for IT4IT systems (and some business domains) with regard to Computer Systems Validation and other regulatory systems. Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management functions for resolution
• Facilitate and leverage quality practitioners within the delivery units to identify best practices, and lead improvement initiatives across functional areas

Stakeholder management and partnering

Impact and complexity

What you’ll need to be successful

Equal Opportunity Employer

Roche is an Equal Opportunity Employer.

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