Roles: Quality Management System

Reviews newly proposed CSV releases for organizational readiness and provides formal approval of new release documentation. Members are drawn from the CAB or their designated delegates, and their review must verify the organization can operate under the new release per the defined schedule.

Governance board that periodically assesses improvement proposals and external regulatory changes, decides on Roche-wide implementation, justifies priorities with impact assessments, and consults on adoption of delivered CSV framework changes. Acts as the final decision authority when consensus cann

Operational board that reviews and schedules accepted improvement proposals, analyzes organizational and documentation impact, defines implementation plans with resource estimates, and monitors delivery and compliance with CSV framework updates.

Reviews new CSV release documentation for technical correctness and completeness, and provides formal signature as a reviewer of the release documentation. Appointed by CAB members representing each organizational and extended area.

Leads implementation of CSV framework changes for a specific release, coordinates review and approval cycles, monitors rollout execution against the plan, and escalates issues. Typically a member of the Group Informatics Quality and Compliance team.

Reviews newly proposed CSV releases for technical correctness and completeness without providing a formal signature. Appointed by CAB members to provide technical expertise during the release development phase.

Managed by Informatics Quality Assurance, responsible for reviewing glossary term requests, consulting with process area SMEs, cross-checking definitions and linguistic quality, updating and publishing approved terms in EDMS and on the myCSV gsite, and ensuring proper communication to SMEs and Proce

The Document Owner for the Roche GxP Data Integrity Standard (SRD-0139481), responsible for governing the global standard that refines GxP data integrity requirements and means of implementation. This role oversees information compliance and records management globally across Roche.

Reviews and approves L1 Policy documents that are GxP-relevant and reviews L2 Directive documents. Ensures quality governance requirements are met for high-level policy instruments.

Approves ITQMS-relevant L3 Process/SOP documents and L4 Instructions (or named designee). Also acts as reviewer for L3 ITQMS-relevant practices providing RDT quality representation.

Approves L3 Process/SOP documents that are practice-related, ensuring alignment with RDT process standards and governance.

Owns the Continuity Management process, responsible for assuring Informatics continuity against disruptive events through business continuity planning and disaster recovery.

Oversees the performance of the IT Quality Management System and provides governance, decision-making, and actions based on inputs from the Management Review of Quality. Identifies quality gaps requiring resource allocation and escalates issues to Informatics Leadership Team when necessary.

Responsible for Quality Assurance of IT infrastructure and qualification, independent oversight ensuring computerised systems meet regulatory requirements and comply with the IT Quality Management System. Ensures validation activities are planned, executed, and finalized in compliance with CSV polic

Authors and reviews computerised system risk management policy documents, ensuring compliance with quality standards and regulatory requirements for computerised systems across the Informatics domain.

Document owner and accountable lead for the IT Quality Management System. Responsible for maintaining the IT Quality Manual, providing quality approval for key QMS artifacts, running the periodic management review process, and ensuring all IT QMS components perform satisfactorily across the Informat

Provides quality oversight on behalf of Pharma Product Development (Contract Giver) for GxP computerised systems managed by RDT. Responsible for conducting periodic risk assessments of Critical to Quality factors, conducting and leading audits, creating and maintaining Data Integrity Quality Briefs

Responsible for independent oversight of GxP computerised systems used by PT, ensuring they meet regulatory requirements and comply with the Roche Pharmaceutical Quality System. Ensures validation activities are planned, executed, and completed in compliance with CSV policy. Oversight is commensurat

Provides independent quality oversight of RDT computerised systems ensuring regulatory compliance with the RDT QMS. Responsible for overseeing validation activities, providing the CSV framework and GxP regulatory guidance, managing vendor risk assessment, ensuring ITSM compliance for GxP systems, as

Ensures the self inspection is conducted in line with established procedures, timelines, and objectives. Coordinates with stakeholders, assigns responsibilities, and facilitates communication throughout the process. The Review Owner is a Process Owner or a member of the Quality Team.

Conducts the actual reviews, performs evaluations of existing processes, and raises recommendations for improvements during self inspections. Members must possess appropriate expertise relevant to the review scope.

Owns the Audit Management process, responsible for planning, conducting, and following up on internal audits and third-party security assessments to ensure continuous compliance.

Holds ultimate accountability for the IT quality management system and for ensuring systems, processes, and people are compliant with applicable regulations. Regularly examines organizational performance to ensure alignment with corporate objectives and regulatory requirements.