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 COMPLEXITYDefine 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
Qualifications
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)
