Quality and Regulatory Compliance Officer

5 months ago

Toronto, Canada Sinai Health Full time

Sinai Health is a leading academic health science centre and a trailblazer for integrated care across the health continuum. Our fusion of science, innovation, care and learning has earned us international, national and provincial leadership for unique programs and compassionate care. Since 2015, Sinai Health has delivered excellent care in hospital, community and home. Comprised of Mount Sinai Hospital, Hennick Bridgepoint Hospital, the Lunenfeld-Tanenbaum Research Institute and our system partner Circle of Care, Sinai Health discovers and translates scientific breakthroughs, pushes boundaries for health solutions, and educates future clinical and scientific leaders.

At Sinai Health, we care, create possibilities and offer hope. Sinai Health is looking a focused and results-oriented **Senior Manager, Quality Program and Patient Services** to support our **Pathology and Laboratory Medicine Department** at our **Mount Sinai Hospital Campus**.

To ensure the Department of Pathology and Laboratory Medicine (PLM) is compliant with all applicable regulatory and safety legislation and accreditation standards; provide content expertise on Quality Management Systems legislations, regulations and best practice standards; provide leadership and guidance on quality to laboratory staff and affiliated organizations and laboratories; actively involved in continuous improvement initiatives of the Quality Management System team of PLM.

The Quality and Regulatory Compliance Officer will:

- Provide guidance to the members of the Quality Committee and quality technologist
- Act as content expert regarding current and proposed quality systems legislation, regulation and best practice and the resultant impacts to the organization
- Provide training for internal auditors, facilitate internal audits, issue audit reports and ensure implementation of corrective actions of non-compliance
- Provide leadership and support through standardization and streamlining of processes, improve support mechanisms and activities in accordance with applicable regulations and legislation including Clinical Laboratory Standards Institute (CLSI) Standards, Laboratory Licensing, Mandatory and Voluntary Laboratory Accreditations, i.e., ACD, ISO 15189, and CAP
- Assist in the development and maintenance of standards of best practice and management of patient care through creation of an environment conducive to growth and development of staff and excellence in practice.
- Promote and foster the goals, policies and procedures of the department in alignment with Sinai Health’s purpose and values
- Escalate identified risks to Senior Lab Management for consideration and mitigation planning
- Keep current on developments, information, trends, legislation, etc. related to quality management systems and compliance
- Under direction from Senior Lab Management liaise/cooperate with accreditation agencies / regulatory bodies in accreditation reviews or investigations
- Create, maintain and deliver Quality Management Systems training programs and activities which promote awareness and compliance within the organization
- Other duties as required

Support for Quality Management Systems includes:

- Development/Maintenance of the Quality Manual
- Monitor completeness of Competency Assessments across the department
- Incident and non-conformance management
- Development and compilation of KPIs
- Safety Program
- Learning and Development (Education database)
- Document Control system
- Internal Audit Program
- External Quality Assessments (EQA) and Performance monitoring
- Reference Laboratory selection
- Job Requirements- Graduate of Bachelor of Science in health sciences or related field
- Graduate of Medical Laboratory Technology Program
- Current registration with the College of Medical Laboratory Technologists of Ontario (CMLTO)
- Completion of Quality Management System, LEAN Six Sigma or similar courses
- Assessor Certificate for Accreditation Canada Diagnostics (ACD) and/or College of American Pathologist (CAP) Assessor preferred
- Minimum 5 years of recent experience in a pathology and medical laboratory and two years in a similar Quality and Regulatory Compliance officer role is required
- Strong knowledge and understanding of Quality Management Systems
- Comprehensive experience with Quality Assurance audits, preferably as a QA auditor/inspector and/or ACD/CAP assessor, including management/implementation of corrective actions and resolutions for non-conformances
- Experience with Change Management.
- Related project leadership experience, i.e. quality improvement, professional practice, safety
- Strong and effective incident investigative and problem solving skills.
- Experienced, knowledgeable in root cause analysis.
- Good knowledge of incident and safety reporting system/software
- Good knowledge of risk assessment and management related to failure to comply with regulatory requirements
- Effective time management and strong organizational skills
- P

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