Salary Range: $74,618-$107,264/year. The starting salary for this position would be determined with consideration of the successful candidate’s relevant education and experience, and would be in alignment with the provincial compensation reference plan. Salary will be prorated accordingly for part time roles.
Job Summary:
In accordance with the Mission, Vision and Values, and strategic directions of Provincial Health Services Authority patient and employee safety is a priority and a responsibility shared by everyone at PHSA, and as such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.
Reporting to the Manager, Quality, Safety and Performance Improvement, the Senior Clinical Quality Specialist is responsible for developing, coordinating, implementing and evaluating continuous clinical quality improvement initiatives for organ donation and transplant programs. The role provides regulatory expertise and consultation to internal and external partners to ensure the safety and quality of organs for transplantation, and that all organ recipients have the best outcomes possible. The role is also responsible for the administration of the Quality Management System for compliance to Health Canada Regulations, CSA Z900 standards, and Accreditation Canada.
Duties/Accountabilities:
• Leads the clinical patient safety program including policies, processes and procedures under the direction of the QA Manager for BCT’s Provincial Organ Donation and Transplantation mandate.
• Collaborates with management and healthcare teams in monitoring and evaluating quality of clinical care and patient outcomes for the transplant patient population based on standards of care as well as the findings of nursing research, hospital policies/procedures and applicable patient care protocols, guidelines.
• Develops, edits and maintains quality protocols, standard operating procedures (SOPs), records and reports to ensure alignment with PHSA, BCT, Health Canada and Accreditation Canada requirements in order to ensure compliance and meeting quality goals. Ensures any changes in protocols and standards are communicated to clinical staff and effectively implemented.
• Manages the comprehensive organ chart audit program by providing training to quality staff, reviewing completed chart audits, responding to escalated technical chart issues, and identifying targets for trending and performance indicators.
• Prepares regulatory submissions and Error/Accident/Adverse Reaction reports as required through the gathering of data and information, completing forms, reviewing and providing guidance to those writing submissions.
• Maintains a comprehensive internal audit and supplier qualification program, generates audit schedules and conducts audits as needed. Manages the Equipment Management Program, and ensures equipment calibration, qualification, routine maintenance and testing activities are performed and documented.
• Manages comprehensive change control and validation programs, including maintenance of electronic documentation and charting systems. Reviews software updates by vendor to ensure no impact to quality systems, performs testing, validation, security, and training of staff, audits for authorized users.
• Develops and manages the quality system infrastructure for clinical processing of Islet Cells at the Ike Barber Human Islet Transplant Laboratory. This includes environmental monitoring, materials management, equipment maintenance and monitoring, change control and document management.
• Reviews findings and reports from root-cause investigations associated with deviations, non-conformances, PSLS, and audits and recommends follow-up and/or implements corrective actions.
• Responds to recommendations and findings arising from Health Canada inspections, external audits, and implements actions to address new regulatory recommendations and writes validation reports for review.
• Works with clinical and operations leaders and staff to, implement, and evaluate service outcomes and performance; prioritize quality initiatives based on program functions, needs and performance measurement system; implements Safety and Quality Improvement education, initiatives and materials including evaluation and sustainment tools.
• Contributes to ongoing development of organ donation/transplant by identifying advancements and trends in safety and Quality Improvement. Gathers and analyzes information and provides recommendations on process improvement initiatives.
• Liaises with provincial and national partners for program development and system improvements including Canadian Blood Services, Canadian Standards Association, and Living Donor Network.
• Manages training program for donation, transplant and quality staff. Proactively educates staff regarding regulatory issues, new statutes and /or guidelines, and safety, quality and risk management activities.
• Develops and maintains collaborative relationships with physicians, management and staff. Serves as a subject matter expert and quality educator for clinical staff members, laboratory personnel and hospital partners.
• Provides guidance/supervision to other Quality Assurance staff, including coaching, mentoring, and training, as assigned.
Qualifications:
A level of education, training, and experience equivalent to a Bachelor’s Degree in Biology/ Microbiology, or other related discipline and minimum five years of direct QA/QC experience in a healthcare/biotech/laboratory/ ISO/GxP environment.
Demonstrated experience in conducting internal audits, record reviews, managing a controlled documentation system preferred. High attention to detail, excellent organizational and time management skills and clear, concise writing and proof reading skills. Ability to interact constructively and efficiently in a cross-functional team environment. Capacity to manage multiple priorities in a regulated environment independently. Skilled use of Word, Excel and other similar programs along with experience with an electronic Quality Management System or Laboratory management System is an asset. Knowledge of the requirements of the Canadian Standards Association and Health Canada relating to cells, tissues and organs, and familiarity with standards of practice such as ISO, GMP/GLP, Accreditation Canada, and/ or Canadian Blood Services criteria considered an asset.
** Please note: Support for nomination with the BC Provincial Nominee Program is not a guarantee, entitlement or an employee benefit after receiving a full time job offer with PHSA**