The Laboratory Medicine Quality and Safety lead

Responsibilities:

• Offering Second level of support for all application/reagents, provides specialized technical support/advice/information by interfacing directly with Customers and appropriate Commercial Support colleagues and functions. Interfaces with GSS and the Local Safety Officer in order to ensure rapid turnaround time of escalated complaints/inquiries.
• Leveraging his/her unique expertise in laboratory medicine, provides guidance to first line of support staff on how to approach, resolve and communicate solutions to the customers, both in a verbal and written format. Also provides coaching to customers as part of a continuing education/skills enhancement program. Collaborate with Sales/Marketing in order to write documents (reports, articles, papers, memos, letters, etc…) that could be used to promote our products. Write documents for customers: the contents of these documents may include correlation results, study protocol, etc.
• Develop and sustain strong relationships with Clinical Biochemists, Medical Biochemists, Pathologists, Laboratory leadership across Canada. Acts as an expert advisor for the customers and Global development and support teams on projects involving reagent applications. Reviews relevant technical update and other literature, undertakes research, attends advanced global application training sessions and product update sessions and maintains an effective knowledge network related to all clinical applications on the different instrument platforms.
• Create and manage a “sentinel” network of Canadian laboratorians to provide an early warning for quality issues of our products
• Assist and support Marketing in their attempts to define more value for our customer with our product offering. Reach out to colleagues of Commercial Support, but also Sales and Marketing in defining customer support solution that delivers value to our customers.
• Establishes Key Performance Indicators for taking cases, entering data, managing customer, escalating complaints to Global, controlling costs, etc.
• Acts as Roche’s trusted advisor with professional associations (e.g. CSCC, IQMH, etc) including maintaining an understanding of the different accreditation requirements and proficiency testing programs in all Canadian provinces. Maintains an open line of communication with these different organizations in order to ensure rapid response to our customer base in case of complaints/inquiries.                          
• Advise Regulatory and product life cycle groups regarding product design and use in Canadian market                                                 
• Collaborate with the Regulatory and Quality teams to represent the interest of Canada commercial organization and its customers for scientific, technical, quality and safety issues
• Responsible for scientific, technical, quality and safety narrative for customer communication
• Coordinate and summarize scientific and technical information from relevant stakeholders for input in Canada product recall and other quality or complaint communications
• Assist the Regulatory and Quality teams in communications with Health Canada 

Requirements:

• Ph D. in Biochemistry or Clinical Biochemistry and post-doctoral diploma in clinical biochemistry or clinical microbiology is a definitive plus
• Certificate degree in management a plus
• Canadian Board (FCACB) or American Board Certification (FACB) or Local Board OCQ specialist
• Member of CSCC or any provincial laboratory medicine clinical society or equivalent
• At least 3 years of experience in Clinical laboratory 
• Several years of hands-on experience with solving problems in the clinical laboratory
• In this position, you will be servicing customers across Canada, therefore a proficient level of English is required and French is required.
• Very good understanding of Laboratory Standards (International and Canadian)
• Leadership skills, excellent communication skills and customer management experience all necessary for this job.
• Experience interacting with Health Canada