Reporting to the Director Quality & Regulatory Affairs the Manager Technical Quality will provide expert knowledge to the technical Quality Team ensuring effective execution and delivery of accountabilities in British Columbia. He/she will provide medical laboratory technical and quality consultation to Operations and the Quality team ensuring LifeLabs’ practices comply with applicable legislation and regulations. The Manager Technical Quality will also ensure that standard provincial/national quality processes are designed, implemented and monitored in all phases; pre-analytical, analytical and post analytical.
ACCOUNTABILITIES:
Act as content expert and consultant regarding current and proposed medical laboratory specific legislation, regulation and best practice and the corresponding impact on the organization
Provide ongoing leadership and support through standardization and streamlining of processes, improved support mechanisms and activities in accordance with applicable regulations and legislation including Clinical Laboratory Standards Institute (CLSI) Standards, Laboratory Licensing, Ontario Laboratory Accreditation (OLA), ISO 15189, Diagnostic Accreditation Program (DAP), College of American Pathologists (CAP), and Medical Services Commission (MSC) protocols
Create and maintain processes and documents (SOPs, forms, validation protocols, job aids, equipment/supply specifications) which support compliance with Quality Systems regulations and best practice in pre analytical, analytical and post analytical processes
Escalate identified risks to senior management for consideration and mitigation planning
Participate on audit and project teams
Participate in the development of key performance indicators and the generation of reports and action plans
Participate in the evaluation of non-conformances, corrective actions and follow-up
Keep current on developments, information, trends, legislation, etc. related to medical laboratory quality management and compliance
Liaise/cooperate with LifeLabs’ business and strategic partners on shared quality concerns
In alignment with the Medical/Scientific team, ensure patient safety initiatives are effectively designed and implemented in all processes
REQUIREMENTS:
Degree or Diploma in Medical Laboratory Technology
Registration with the Canadian Society of Medical Laboratory Science is required
A minimum of 7 years’ experience as a medical laboratory technologist
Certification in Lean/Six Sigma and/or Laboratory Quality Management Systems is an asset
Requires strong Quality Systems knowledge and understanding, to provide expert support to all customers, internal and external
Proven competence in facilitating the processes used to design, develop, validate, implement, monitor, control and continuously improve a Quality Management System within a regulated environment
A clear understanding of regulatory enforcement procedures and the business impact of failing to meet external regulatory requirements
Ability to educate others and promote cultural and procedural change in a Quality Systems environment
The ability to use sound risk management analysis to assess the regulatory and business impact of prioritizing goals
Facilitation skills necessary to lead discipline specific teams, and the confidence to conduct audits, issue non-conformance reports requiring corrective actions and follow-up on continued non-compliance
Requires excellent communication skills both written and verbal
Requires strong organizational, change and incident and project management skills to ensure that deliverables are achieved on schedule in a controlled manner
