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

Connect and understand the regulatory and compliance needs in the context of the stakeholders and closely partner with them to develop the strategic direction of the product. Shape the Digitalized Compliance roadmap and portfolio to deliver high value outcomes for the customers of the product. Define and deliver the product roadmap and manage the end-to-end product lifecycle (including continuously facilitating product discovery), ensuring it delivers tangible and meaningful value aligned with customer needs and expected business outcomes

Collaborate to create the future IT Governance Framework with IT processes and standards to keep these updated with the newest developments of external standards and best practices

Coordinate, connect and collaborate across informatics to foster a spirit of One Roche

Impact and complexity

Define and manage product service levels, governance and operational support model aligned with stakeholder needs. Lead or coordinate quality and compliance discussions. Ensure stability, quality and transparency in all aspects of the product governance and partner with senior / global leaders to ensure compliance with existing and changing regulations

Demonstrate a working knowledge and implications of general and Roche-specific information security, privacy and regulatory principles and requirements. Ensure that services are designed, delivered and maintained in accordance with applicable information security, privacy and regulatory requirements. Ensure information risk assessment process and implementation guidelines are followed

What you’ll need to be successful

Exhibits servant and creative leadership (VACC) behavior. Exhibits a Lean-Agile Mindset and excels at Product Management practices. Takes progressive risk—not thrill-seeking, but risk that leads to opportunity

Has a keen Quality & Regulatory focus : You are passionate about major trends. Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and manages complexity

Has an enterprise mindset that can break down silos. Focus on continuous delivery through collaboration, and bringing people together to work towards the same purpose across organizational boundaries

Exhibits ability to empower teams and individuals to act autonomously and hold them accountable. Exhibits intellectual curiosity and integrity and has a strong passion for innovation

Understanding of health regulatory frameworks (FDA, GxP); Understanding of risk and control frameworks and quality standards including government guidelines and laws (HIPAA, GDPR, experience with control automation)

Equal Opportunity Employer Roche is an Equal Opportunity Employer.

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