Timothy Blair Email and Phone Number

Strong leader who partners across all Diagnostics sites and Affiliates to deliver high quality products to customers and patients, ensures our right to operate and helps create value through process excellence and continual improvement efforts. As the Head of Global Safety Board Diagnostics, is a member of the Roche Diagnostics (RD) Post Market Quality leadership team and a key representative of the organization to Roche Affiliates. Chairs the RD Global Safety Board and leads a high performing team of Global Safety Board Managers. As the Head of the Global Safety Board Diagnostics (Head Global SB) is accountable for product safety, in particular but not limited to adverse event/serious incident related aspects of the RD Post Market Surveillance System. Accountable for the safety of on market diagnostics products and solutions, in particular but not limited to the evaluation of the risk of potential product safety issues as well as addressing verified product safety issues. Accountable for the respective decision(s) taken by the Global Safety Board; this includes the initiation and monitoring of appropriate field corrections and removals. As part of the scope of the position, partner with Subject Matter Experts in the Clinical Development and Medical Affairs organization as well as the RD Affiliates / Regions and other Roche stakeholders.Additional Responsibilities• Enable and implement smart, risk-based compliant processes that result in efficient and effective decision-making to ensure patient and customer/user safety.• Build effective relationships with affiliates and partners with Quality Site Heads and Local Safety Officers in the Affiliates with special focus on proactive communication regarding product issues of on market diagnostic products and solutions.• Oversees the Global Safety Board process through adequate monitoring and KPIs of the end-to-end timeliness of the process from first contact to decision-making, reporting, and execution.

-Responsible for developing and implementing the mid- to long-term strategic focus of the CIR RMD Reagent Life Cycles and RSS Organization while ensuring alignment with the strategic plan of the global and local organizations including, organizational development, competencies, and human and fiscal resource planning.-Leads, through Life Cycle-based Department Heads, a functional team of case resolution specialists responsible for the end to end resolution of complaints and inquiries for RMD Reagent Life Cycle and RSS products.-Establish operating policies and procedures that effect the CIR RMD Reagent Life Cycles and RSS. -Builds infrastructure and implements harmonized Case Resolution processes and procedures across the Business Units.-Defines scope and articulates process improvements that will enhance the efficiency, productivity and timely case resolution by collaborating and interfacing with Quality, Regulatory and Operations groups as well as global organizations to harmonize and leverage product support services.-Provides strategic insight and operational focus for the support of RMD Reagents and RSS products. -Responsible for establishing and achieving functional goals-Responsible for the compliance of the function with regulatory and ISO Quality system requirements.-Provides strategic insight and direction during regulatory inspections, including, direct interaction with authorities and backroom leadership across functional areas. -Manages the group financially. Is accountable for the capital budget and related expenses.-Provide complaint management and customer support guidance, as needed, to all functional areas.-Leads / supports cross-functional project teams for projects impacting both global and local organizations

• Leading the Quality Systems and Compliance Team with responsibility for quality compliance and quality systems activities• Responsible for assuring strategic direction for overall compliance with FDA Quality System Regulations, Medical Device Directives, and ISO standards. Primary responsibilities include oversight of Quality Compliance programs and processes, including Medical Device Vigilance (MDV), Field Actions (Safety Board), Internal Audits, and CAPA• Establishing procedures and practices for conducting quality audits and ensures that such audits are conducted to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system• Developing and implementing the strategies, processes, policies and plans which define regulatory inspection readiness and response planning• Responsible for ensuring quality systems are designed, implemented, and effective• Managing the Quality Systems and Compliance department resources including planning, budget administration, human resource development

Head, Quality Systems and ComplianceLead a team of quality specialists to support the Quality and Regulatory compliance activities associated with on-market products and Corrective and Preventive Actions. Oversaw the management of the Training, Supplier Quality and Quality System programs.

Safety Board, Vigilance & CAPA Lead a team of quality specialists to support the Quality and Regulatory compliance activities associated with on-market products and Corrective and Preventive Actions.