Local Quality Responsible

Local Quality Activities:

• Propose, lead, participate in and actively contribute to the Affiliate and Global Networks, by sharing knowledge, enhancing stakeholder collaboration, promoting quality mindset and co-creation of quality solutions
• Lead the implementation of the global Roche Quality Management System (QMS) at Affiliate level to meet regulatory requirements
• Lead the process to measure the overall Affiliate Medical Compliance status and take actions as needed
• Lead the Risk and Opportunity management and escalation process at local level to proactively identify, manage, mitigate and escalate Medical Compliance risks
• Identify the need for establishing an affiliate quality monitoring strategy in collaboration with relevant local and global stakeholders, in the areas of QMS and Medical Compliance
• Support Audits and Inspections impacting Affiliates
• Undertake other quality responsibilities that may arise in emerging Quality areas (e.g. Healthcare Solutions, RWE, medical devices) as per business needs, work packages and/or as defined in local/global procedures, systems, regulations and requirements

Market Research and Patient Support Program:

• Devise strategic oversight plan within the Affiliate/Global Function to identify MAPs through budgeting, market and brand planning information
• Support the organization (activity/program owners) in the identification and classification of all activities that could potentially qualify as MRPs or PSPs