Manager, Regulatory Compliance

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.

• 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 representative, and not necessarily all-inclusive.

• Proactive predisposition
• Requires strong Quality Management 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 verbal communication skills to effectively communicate decisions and seek input
• Requires excellent technical writing skills to create and maintain documentation.
• Requires strong organizational, change and incident and project management skills to ensure that deliverables are achieved on schedule in a controlled manner
• Intermediate to advance computer skills and proficient in Microsoft Office

• Every worker is to work in a manner that protects his or her own health & safety as well as the safety of those co-workers and others. Workers are to work in a manner that is consistent with the law and with safe work practices and procedures established by LifeLabs.

• Every worker is to work in a manner that protects his or her own health & safety as well as the safety of those co-workers and others. Workers are to work in a manner that is consistent with the law and with safe work practices and procedures established by LifeLabs.

Minimum Education:   Degree or Diploma in Medical Laboratory Technology. Training or certification in Lean/Six Sigma and/or Quality Management Systems an asset.

Professional Registration:  

Ontario: College of Medical Laboratory Technologists of Ontario (CMLTO)

BC: Canadian Society of Medical Laboratory Science (CSMLS) certification required.

Experience: 
Seven years previous medical laboratory experience required.

Regular Hours of Work:  
37.5 hours per week. Additional hours as required.

Working Environment:
Office and Operations environment. Travel required.