Main tasks: * Accountable for the timely handling of individual cases (Inquiry, Complaint, Potential Reportable and Safety issues) according to ISO Quality System requirements and regulations, and needs of the Country Organizations, including creation, acceptance, classification, investigation, complete documentation, on-site trouble-shooting and resolution of cases. * Resolve cases in the assigned area, potentially requiring consultation with more senior team members on technical or process-related aspects. * Assume responsibility to ensure, by collaborating and interfacing with the BA and global and/or local functions, appropriate measures from cases are derived, including, but not limited to workarounds, in a timely manner. * Assume responsibility for ensuring risk assessments for product quality issues are complete. * Participate in the on-boarding and mentoring activities of new employees and team members, as assigned. * In Case Handling and Affiliate Support (CHAS) - Primary Interface with Affiliates, assuming responsibility for timely communication of quality related information to the Country Organizations. Supports initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives. * In Complaint Investigation and Resolution (CIR) - Responsible for experimental design of complaint investigations, and conducting investigation experiments. Partners primarily with internal Roche Global Functions (i.e. Operations, Research and Development, CDMA). * Analyze data using statistical measures for determining a potential product performance issue. * Responsible for escalating cases which cannot be directly resolved to appropriate levels and initiating further investigation / communicating case-derived information as appropriate. * Assume responsibility for timely communication of quality related information to the Country Organizations. * Proficiency in English (B-level), expressed communication skills and intercultural competence. * Ensure cases are compliant and conform to established quality processes, standards, and regulations. * Support product teams by providing information from cases in order to update product documentation. * Contribute to initial and continuous knowledge transfer from manufacturer, R&D or GCS for new products in the project phase to ensure availability of comprehensive system knowledge. * Create “notifications” (bulletins and communications to affiliates and, ultimately, customers via the local organizations); approve notifications received. * In RIS&SSW: May browse the code repository and consult source code files when required to ensure a correct investigation but never making any modifications in the repository or the checked-in source code. * Work autonomously, with minimal supervision. Additional tasks: * May provide audit and inspection support as requested. * May contribute to the creation of regular reports to document on-market product quality and performance, to escalate critical issues to the responsible Life Cycle Teams and to define proactive measures. * May support regular review of quality of case handling and analyze feedback on customer satisfaction to permanently optimize processes to increase quality and efficiency standards with a focus on customer, compliance and continuous improvement. * May initiate complaint CAPAs and/or nonconformities and perform any assigned CAPA tasks. * May represent the PMQ on cross-team meetings and projects. * May act as a proxy for a Senior role. * May lead or contribute with skills to projects e.g. Squads/Communities of Practice. * The essential job functions and major contributions listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. May be required to perform other duties as assigned to meet the PMQ goals and objectives, as appropriate. For all employees: * Permanently optimizes processes in order to increase quality and efficiency standards.
