Quality & Compliance Specialist (CSV, GMP, GCP)

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

Our ambition is to empower Integrated Informatics to deliver quality and compliance in an efficient way, right the first time.

As part of the Quality Assurance team, you will be a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle. You are a customer-focused, highly collaborative individual who will work with delivery units across both Business and Informatics to advance existing and emerging business critical technology according to Roche’s needs.

WHAT YOU’LL BE WORKING ON

You will assure that Roche’s regulated / critical systems and services adhere to regulatory standards (e.g. 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.

• 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 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

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.

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