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Manager, Regulatory Compliance

3 weeks ago

Burnaby, Canada LifeLabs Full time

For over 50 years, LifeLabs has been Canada’s leading provider of laboratory diagnostic information and digital health connectivity systems, enabling patients and healthcare practitioners to diagnose, treat, monitor and prevent disease. We are passionate about empowering healthier Canadians through accessible, accurate, and innovative diagnostic services.
We are committed innovators, operating Canada's first commercial genetics lab, and the country's largest online patient portal, with more than 8 million Canadians receiving their results online. More than 112 million laboratory tests come through LifeLabs’ laboratories annually, and our team of more than 6,000 passionate, caring, and diverse professionals works together as one to provide high quality testing and results that Canadians can trust.
We know that behind every lab requisition, sample being tested, or investment in technology is an individual and their family counting on us. At LifeLabs, you can make a meaningful impact on Canadians’ lives every day.
Our teams are at the heart of everything we do. We are proud to be recognized as one of Canada’s Best Employers, reflecting our deep commitment to our core values of caring, agility, teamwork, and a customer-centered approach. As part of this commitment, LifeLabs prioritizes the ongoing development of our diversity, equity, and inclusion (DEI) program to better serve the needs of our diverse workforce and the communities we serve. We continue to take steps to challenge ourselves to act with courage and integrity, and to create an environment where people can be their true selves.
These values are not just words on a page, they guide our actions and decisions every day and have come to define our team culture.
**ROLE TITLE**: Manager, Quality and Regulatory Compliance
**REPORTING TO**: Senior Manager, Quality & Regulatory Affairs BC/ON
**Status**: Full Time
**Schedule**: Mon
- Fri
**Additional Requirements**: N/A
**Number of Positions**: 1
**Start Date**: ASAP
**Internal Application Deadline**: 20 June 2025
**PURPOSE OF THE ROLE**:

- Provide expert knowledge and leadership in the area of Qualityand Regulatory Compliance ensuring effective execution and delivery of accountabilities.
- He/She will lead the Quality and Regulatory compliance team (if required) and provide medical laboratory technical and quality consultation to the Medical Scientific Team, Lab Operations, Client services and other areas of LifeLabs ensuring LifeLabs’ practices comply with applicable Quality Standards, legislation and regulations.
- The Manager of Quality and Regulatory Compliance will ensure that the standard provincial/national quality processes are designed, implemented and monitored in all phases; pre-analytical, analytical and post analytical.

**ACCOUNTABILITIES**:

- Provide active leadership and development to all direct and indirect reports, ensuring all individual and team accountabilities are delivered upon.
- Actively contributes to the development of the operating budget in conjunction with the

Sr. Manager.
- Act as content expert and consultant regarding current and proposed quality systems legislation, regulation and best practice and the corresponding impact to the organization
- Provide ongoing leadership and support through national 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, Accreditation Canada Diagnostics, ISO 15189, Diagnostic Accreditation Program (DAP), College of American Pathologists (CAP) and Medical Services Commission (MSC) protocols.
- Oversee and/or support the regulatory compliance team, Medical Scientific, Lab Operations, Clients Services and other areas of LifeLabs in their roles including:

- Quality Management system
- Document Management system
- Learning and Development
- Licensing and accreditation program
- Internal Audit Program
- External Assessments (AC Diagnostics, CPSA, CAP, DAP etc.)
- Reference Laboratory selection and monitoring program
- Competency Assessment
- Non Conformance Management System
- Risk Management
- Issues Management
- KPI Process
- Support other departments within LifeLabs
- Escalate identified risks to senior management for consideration and mitigation planning
- Participate on project teams and improvement initiatives as required
- Keep current on developments, information, trends, legislation, etc. related to quality management systems and compliance
- Liaise/cooperate with health authorities, regulatory bodies and accreditation agencies in compliance reviews or investigations
- 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

The foregoing described accountabilities are representati