Manager, Quality, Regulatory Affairs and Customer Service

Manager Quality Regulatory Affairs and Customer Service

Location: Toronto-661 University

Department: Quality Regulatory Affairs and Customer Service

To provide leadership in the management and administration of the Quality Regulatory Affairs Biosafety and Customer Service portfolios to support functions such as diagnostic services incident and outbreak response surveillance programs research and development customer service quality assurance safety stakeholder relations planning human resources facilities budgets and other special projects as assigned ensuring deliverables resources and service requirements are met.

Key Responsibilities-

• Establishes and maintains a thorough understanding of all relevant guidelines requirements legislations and regulations for the following: Accreditation Canada Diagnostics (ACD) and Canadian Association for Laboratory Accreditation (CALA) Public Health Agency of Canada (PHAC) and any other accreditation/certification/regulatory standards wherever applicable.
• Works collaboratively with the lab management team ensures that all laboratory testing meets accreditation as set out by ACD CALA PHAC and assists managers as necessary to complete annual licensing applications and manage risks.
• Organizes and leads the development and implementation of an evolving Laboratory Customer Service Centre (CSC) responsible for receiving responding to or redirecting all inquiries complaints and issues from across the Province to the Public Health Ontario (PHO) Laboratory; develops and monitors customer service standards establishes and reports on performance metrics and ensures appropriate outreach to customers across the province.
• Provides leadership with Quality Assurance (QA) and regulatory affairs guidance and training.
• Manages procurement of goods and services as required to fulfill the needs of the Quality Assurance Portfolio (QAP) Biosafety and CSC departments.
• Maintains coordinates and audits the comprehensive quality management system (QMS) and ensures it is updated to meet industry best practices.
• Oversees risk management issues within PHO Laboratory including incident reporting and complaints.
• Leads projects which may be concurrent from concept to implementation including initiating and promoting new projects which will make the QAP Biosafety and CSC more effective.
• Develops performance measurement and quality indicators and reviews the indicators regularly to maintain the desired level of efficiency and proficiency.
• Prepares and presents necessary information for monthly and quarterly reviews such as balanced score cards cost centre monthly reports annual management review documents.
• Provides facilitation to gather input from and respond to the needs of medical and scientific staff and relevant managers to ensure portfolio objectives are aligned with the PHO Laboratory plans.
• Advises the director and senior lab management team on issues related to quality/process improvement risk and customer service.
• Works in conjunction with other managers to continuously improve the quality system by harmonizing quality and safety practices across all PHO Laboratory sites.
• Develops program operational plan and goals in support of PHOs overall Annual Business Plan andStrategic Plan.
• Manages budget service and performance indicators and ensures consistency in corporate requirements and approval processes for financial human resources information technology operational and business planning functions.
• Builds and leads teams of multi-disciplinary staff in support of PHOs activities.
• Manages staff congruent with PHO internal policies and procedures professional standards Collective Agreement requirements and other relevant standards legislation or regulations.
• Assigns staff responsibilities setting clear performance objectives and measures evaluating performance; advises on training needs participates in recruiting/selection of staff; addresses performance and disciplinary issues responding to grievances in conjunction with PHO Human Resources management programs; establishes and implements work/vacation schedule; builds and leads a team of multi-disciplinary staff who support PHOs activities.
• Models organizational values and organizational culture and embeds values into area of responsibility.
• Act as a designated lead and/or subject matter expert on cross functional PHO teams to ensure linkages and collaboration across PHO.
• Represents the Unit its initiatives and services and PHO in consultations relationships and collaborative partnerships with government other provincial agencies non-governmental
• organizations professional associations and other academic and community partners. Liaises with Ministry staff on planning and performance matters where applicable.
• Ensures alignment of unit goals objectives and activities with other PHO initiatives goals and objectives.
• Contributes to the development and implementation of the departments mandate and operating procedures by taking a significant role in the identification of new programs and projects that fit PHOs mandate; suggests areas for improvement in internal processes along with possible solutions.
• Keeps abreast of the latest research and developments in area of specialty within PHO and at other agencies.
• Supports PHO in the provision of response in an emergency pursuant to responsibilities as delegated in an emergency response plan; supports PHOs 24/7 incident and emergency response through shared participation in on-call schedule as required.
• Other duties as assigned.

Knowledge and Skills-

• Experience managing a quality management system.
• Knowledge of all relevant guidelines requirements legislations and regulations for the following: Accreditation Canada Diagnostics (ACD) Public Health Agency of Canada (PHAC) and Canadian Association for Laboratory Accreditation (CALA) and any other accreditation/certification/regulatory standards wherever applicable.
• Skill and proficiency with standard computer systems and software programs for word processing spreadsheet presentation sharing and collaboration tools such as Microsoft Office (Word Excel PowerPoint) SharePoint.
• Understanding of current industry information systems particularly as they apply to laboratory services to enhance and modernize the quality and delivery of laboratory services.
• Demonstrated organizational skills including priority setting and time management to manage multiple concurrent issues and projects and provide direction to the reporting staff.
• Demonstrated ability to implement operational changes in an effective and efficient manner.
• Knowledge about the processes involved in resolving service-related issues when highlighted by a customer.
• Established ability to lead guide advise train and mentor a quality and customer service team.
• Project management and financial budget management skills.
• Experience with quality improvement tools such as LEAN principles TQM/CQI Six Sigma is preferred.

Education and Experience-

• Bachelors degree with a relevant chemical physical or biological science as a major subject.
• Practicing certificate of registration with the College of Medical Laboratory Technologists in Ontario (CMLTO) in good standing.
• Five (5) years of relevant laboratory training and experience (or combination of education and experience satisfactory to PHO).
• Two (2) years experience managing day to day supervisory functions of team.
• Three (3) years experience maintaining a quality management system.
• Two (2) years experience in providing customer service support.
• Masters Degree with a relevant chemical physical or biological science as a major subject is preferred.
• Management experience within a union environment is preferred
• Bilingualism (French) is preferred.

Attributes and Competencies-

• Oral and written communication skills to prepare comprehensive proposals briefings and reports develop informational materials and make presentations to management and stakeholder forums.
• Interpersonal communication skills to develop and maintain effective and collaborative working relationships with operations director and senior leadership team medical and scientific staff as well as resources at multiple levels in the organization.
• Interpersonal skills to influence others to accomplish change across PHO/PHO Laboratory departments and program areas.

Duration: Permanent

Hours of Work: Full time 36.25 hours per week

Compensation Group: Manager

Posting Date:

Closing Date:

Please note: applications will be received no later than 11:59pm on the date preceding the closing date as indicated on the Job Requisition.

Note: Internal candidates will be considered first.

While we thank all applicants for their interest only those selected to move forward in the recruitment process will be contacted. Any information obtained during the course of recruitment will be used for employment recruitment purposes only and not for any other purpose.

PHO is committed to ensuring equity in employment. Our goal is to create a diverse inclusive workforce that reflects the communities we serve and to ensure our services and communications are accessible to all individuals. Any candidate who requires a job posting in an alternative format may email a request to Once an applicant has been selected for an interview they can inform PHO about any accommodations they may require at any stage of the interview process.