Yasser Sha

Quality Patient Safety Director

Dear hiring team,

It is with great interest and passion that I submit my application for your consideration. Putting patients and clients first and driving high-quality work are my top priorities. My experience as the Quality, Patient Experience, and Risk Director at Muskoka Algonquin Healthcare in Canada and Quality & Compliance Manager with Trillium Health Partners and teaching experience with the University of Manitoba has allowed me to demonstrate and hone my leadership and academic skills. My experience in leading projects, redesigning processes, and quickly analyzing and solving problems gives me the ability to excel in these positions. I have an extensive background in quality, risk analysis, performance monitoring, and regulatory affairs; this includes leading and acting as the main resource in several successful audits carried out by Accreditation Canada, Health Canada, OLA, and FACT.

Highlights of my professional career and education that may be of interest to you: 

• Participated in multiple projects and province-wide capacity-building initiatives to reduce stem cell transplant wait times. 
• Involved in the implementation and validation of electronic medical record systems (Mosaiq and Sovera and Epic).
• Delivered high-level training on SOPs and regulatory standards and practices.
• Responsible for the development, revisions, and document control of 120 SOPs.
• Investigated patient incident reports, identified root causes, and risks, and implemented corrective actions when required. 
• Assisted in the development of quality performanceindicators for daily operations.
• Reviewed and approved batch release reports for therapeutic cells used for the Stem cell & bone marrow program’s patients (CAR-T cell) 

• Negotiating agreements and contracts with third-party service providers and suppliers, including the development of MOUs. 
• Implementing training programs, writing and approving SOPs and internal policies. 
• Currently the instructor of the Quality Improvement Principles and Procedures course at the University of Manitoba.

• Graduated from the Masters of Healthcare Quality, Safety and Risk Management from Queen’s University in Kingston, ON. (2016)
• Completed Lean and Six Sigma – Green Belt training (2016)
• Completed ASQ CQA certification (2013).
• Received Pharmaceutical Quality Operations and Regulatory Affairs postgraduate diploma (2012).

Sincerely,

Yasser Shaker, M.Sc, RAQC, ASQ CQA Date: June 21st, 2023

Qualifications Summary

• Quality and Patient Experience Executive Director with 15 years of experience in quality, clinical management, safety, and risk analysis, patient experience, trend interpretation, report and protocol writing, incidents investigation, and customer service.
• University instructor for Quality Improvement courses.
• Exceptional management, leadership, and presentation skills.
• Driven towards fostering a patient-centered environment.
• Strong knowledge of Accreditation Canada, GMP, ISO, CSA, OLA, FACT standards.
• Received training on Lean and Six Sigma–Green Belt principles.
• Active member of the Canadian Association of Professional Regulatory Affairs (CAPRA), the American Society of Quality (ASQ), and a Certified Patient Safety Trainer (CPSI).

Leadership

• Led and acted as the main authority for the Quality department; provided leadership for the accreditation process and ongoing accreditation activities. 
• Provided direction in the development, implementation, and evaluation of the hospital Quality Improvement Plan.
• Provided leadership to staff in hiring, orienting, and training processes. Ensured training requirements are maintained to required standards.
• Chaired a monthly Quality and Patient Safety staff committee meeting aimed at driving the action-oriented quality culture.
• Participated in capacity planning committees at HHS and THP as required. 
• Involved in budget planning and contract negotiations. 

• Acted as the primary contact for Accreditation Canada, Health Canada, FDA, and FACT for all matters (including audits).
• Worked cross-functionally and constructively with senior management, as well as staff of all levels of the organizational hierarchy, to reach consensus and ensure all specifications and regulatory requirements are met.
• Provided educational tools to staff by delivering presentations on Quality Improvement topics.

• Identified incidents and non-conformances, conducted root-cause analyses and facilitated quality performance reporting.
• Responsible for conducting, following up, and resolving internal audits and citations. Ensured timely resolution of incident investigations, audit and regulatory inspection findings.
• Ensured completion of follow-ups to verify implementation and effectiveness of Corrective/Preventative Actions (CAPAs) resulting from risk management investigations.
• Completed specification deviation reports to ensure compliance and resolved all regulatory and quality compliance issues.
• Provided guidance and leadership for quality improvement projects and quality maintenance. 
• Collaborated with Infection Control department and was heavily involved in infection control initiatives and projects.
• Supervised information management and data mining processes used to document, track, and report on all aspects of the patient-related investigation.
• Performed internal audits and submitted procedure manual revisions.
• Interpreted and ensure staff training and compliance with SOPs, policies, procedures, and regulatory guidelines.
• Ensured effective monitoring by the Quality Operations Department of all systems impacting the quality of products and processes. Ensured that deviations were fully investigated and products met all quality requirements before release and distribution.

• Prepared and coordinated the submission of license applications, amendments, and site licenses. 
• Reviewed and updated the organization’s SOPs for quality management systems, at least annually. Ensured document control and approval process as per hospital requirements. 

Director of Quality, Risk, and Patient Experience 2022 - Present

Muskoka Algonquin Healthcare Huntsville, Canada

Senior Quality Improvement & Risk Leader 2021 - 2022

Lakeridge Health Ajax, Canada

Quality Assurance & Improvement Manager 2019 - 2021

Saint Elizabeth Healthcare Toronto, Canada

Quality & Accreditation Manager 2017 - 2019

Trillium Health Partners - Credit Valley, Mississauga and Queensway Hospitals Mississauga, Canada

Quality, Patient Safety and Risk Manager 2012 – 2017

Hamilton Health Sciences - Juravinski Hospital Hamilton, Canada

Lecturer- Quality Improvement Principles and Procedures 2016 - 2022

University of Manitoba Winnipeg, Canada

Lecturer and Program Development Manager - Quality Improvement 2014 - 2016

Evergreen College Toronto, Canada

Quality Specialist - Quality Operation & Quality Control 2011 - 2012

Novartis – Ciba Vision Sterile Manufacturing Mississauga, Canada

Lab Technologist/Microbiologist - Quality Operation 2009 - 2011 Sanofi Pasteur Toronto, Canada

Education & Certification

Master of Science in Healthcare Quality, Safety and Risk Management 2016

Queen's University Kingston, Canada

Christopher Leadership Course 2014

McMaster University Hamilton, Canada

Certified Patient Safety Officer (CPSI) 2014

Canadian Patient Safety Institute Kingston, Canada

Quality Auditor Certificate 2014

American Society of Quality Toronto, Canada

Postgraduate Diploma in Quality Assurance and Regulatory Affairs 2013

Seneca College Toronto, Canada

Bachelor of Science in Biology, with honours 2011

Ryerson University Toronto, Canada

Initiatives and Non-peer Reviewed Work: 

1. Presentation – FACT, Health Canada, and Accreditation Canada Survey, Hamilton Health Sciences, 2015 
2. Master’s Thesis – The Effectiveness of Hand Hygiene Compliance Initiatives and its Impact on Infection Rates in Acute Healthcare Setting, Queens University, Master’s of Healthcare Quality, 2016 
3. Project – Onboarding Process for Physicians and Nurses, Hamilton Health Sciences, 2016 
4. Project – Document Management System, Hamilton Health Sciences, 2016
5. Project –Stem Cell and Bone Marrow Transplant Program Unit Expansion, Hamilton Health Sciences, 2017 
6. Project –Validation of autoclaves and sterilization equipment, Hamilton Health Sciences 2017 
7. Patient Safety incident categorization, Trillium Health Partners, 2018 
8. Interview – The Rewards of Quality Management, University of Manitoba Extended Education, 2018 
9. Interview – Online Courses Fit into your Life and Advance your Career, University of Manitoba Extended Education, 2018 
10. Project – Implementation of ThedaCare in healthcare, Trillium Health Partner, 2018
11. Project – Epic Health Information System implementation, Lakeridge Health, 2021
12. Presentation – Learning from Experience Lean in Healthcare, Lakeridge Health, 2021 
13. Project – Improving Portering Delays in Diagnostic Imaging and Emergency, Trillium Health Partners, 2017
14. Project – ECG/EKG Ordering Process Improvement, Lakeridge Health, 2021 Project – Staff Scheduling System Upgrade, Lakeridge Health, 2021
15. Presentation and Project – Implementation of Tiered Huddles, Lakeridge Health, 2021

Dear hiring team,

It is with great interest and passion that I submit my application for your consideration. Putting patients and clients first and driving high-quality work are my top priorities. My experience as the Quality, Patient Experience, and Risk Director at Muskoka Algonquin Healthcare in Canada and Quality & Compliance Manager with Trillium Health Partners and teaching experience with the University of Manitoba has allowed me to demonstrate and hone my leadership and academic skills. My experience in leading projects, redesigning processes, and quickly analyzing and solving problems gives me the ability to excel in these positions. I have an extensive background in quality, risk analysis, performance monitoring, and regulatory affairs; this includes leading and acting as the main resource in several successful audits carried out by Accreditation Canada, Health Canada, OLA, and FACT.

Highlights of my professional career and education that may be of interest to you: 

• Participated in multiple projects and province-wide capacity-building initiatives to reduce stem cell transplant wait times. 
• Involved in the implementation and validation of electronic medical record systems (Mosaiq and Sovera and Epic).
• Delivered high-level training on SOPs and regulatory standards and practices.
• Responsible for the development, revisions, and document control of 120 SOPs.
• Investigated patient incident reports, identified root causes, and risks, and implemented corrective actions when required. 
• Assisted in the development of quality performanceindicators for daily operations.
• Reviewed and approved batch release reports for therapeutic cells used for the Stem cell & bone marrow program’s patients (CAR-T cell) 

• Negotiating agreements and contracts with third-party service providers and suppliers, including the development of MOUs. 
• Implementing training programs, writing and approving SOPs and internal policies. 
• Currently the instructor of the Quality Improvement Principles and Procedures course at the University of Manitoba.

• Graduated from the Masters of Healthcare Quality, Safety and Risk Management from Queen’s University in Kingston, ON. (2016)
• Completed Lean and Six Sigma – Green Belt training (2016)
• Completed ASQ CQA certification (2013).
• Received Pharmaceutical Quality Operations and Regulatory Affairs postgraduate diploma (2012).

Sincerely,

Yasser Shaker, M.Sc, RAQC, ASQ CQA Date: June 21st, 2023

Qualifications Summary

• Quality and Patient Experience Executive Director with 15 years of experience in quality, clinical management, safety, and risk analysis, patient experience, trend interpretation, report and protocol writing, incidents investigation, and customer service.
• University instructor for Quality Improvement courses.
• Exceptional management, leadership, and presentation skills.
• Driven towards fostering a patient-centered environment.
• Strong knowledge of Accreditation Canada, GMP, ISO, CSA, OLA, FACT standards.
• Received training on Lean and Six Sigma–Green Belt principles.
• Active member of the Canadian Association of Professional Regulatory Affairs (CAPRA), the American Society of Quality (ASQ), and a Certified Patient Safety Trainer (CPSI).

Leadership

• Led and acted as the main authority for the Quality department; provided leadership for the accreditation process and ongoing accreditation activities. 
• Provided direction in the development, implementation, and evaluation of the hospital Quality Improvement Plan.
• Provided leadership to staff in hiring, orienting, and training processes. Ensured training requirements are maintained to required standards.
• Chaired a monthly Quality and Patient Safety staff committee meeting aimed at driving the action-oriented quality culture.
• Participated in capacity planning committees at HHS and THP as required. 
• Involved in budget planning and contract negotiations. 

• Acted as the primary contact for Accreditation Canada, Health Canada, FDA, and FACT for all matters (including audits).
• Worked cross-functionally and constructively with senior management, as well as staff of all levels of the organizational hierarchy, to reach consensus and ensure all specifications and regulatory requirements are met.
• Provided educational tools to staff by delivering presentations on Quality Improvement topics.

• Identified incidents and non-conformances, conducted root-cause analyses and facilitated quality performance reporting.
• Responsible for conducting, following up, and resolving internal audits and citations. Ensured timely resolution of incident investigations, audit and regulatory inspection findings.
• Ensured completion of follow-ups to verify implementation and effectiveness of Corrective/Preventative Actions (CAPAs) resulting from risk management investigations.
• Completed specification deviation reports to ensure compliance and resolved all regulatory and quality compliance issues.
• Provided guidance and leadership for quality improvement projects and quality maintenance. 
• Collaborated with Infection Control department and was heavily involved in infection control initiatives and projects.
• Supervised information management and data mining processes used to document, track, and report on all aspects of the patient-related investigation.
• Performed internal audits and submitted procedure manual revisions.
• Interpreted and ensure staff training and compliance with SOPs, policies, procedures, and regulatory guidelines.
• Ensured effective monitoring by the Quality Operations Department of all systems impacting the quality of products and processes. Ensured that deviations were fully investigated and products met all quality requirements before release and distribution.

• Prepared and coordinated the submission of license applications, amendments, and site licenses. 
• Reviewed and updated the organization’s SOPs for quality management systems, at least annually. Ensured document control and approval process as per hospital requirements. 

Director of Quality, Risk, and Patient Experience 2022 - Present

Muskoka Algonquin Healthcare Huntsville, Canada

Senior Quality Improvement & Risk Leader 2021 - 2022

Lakeridge Health Ajax, Canada

Quality Assurance & Improvement Manager 2019 - 2021

Saint Elizabeth Healthcare Toronto, Canada

Quality & Accreditation Manager 2017 - 2019

Trillium Health Partners - Credit Valley, Mississauga and Queensway Hospitals Mississauga, Canada

Quality, Patient Safety and Risk Manager 2012 – 2017

Hamilton Health Sciences - Juravinski Hospital Hamilton, Canada

Lecturer- Quality Improvement Principles and Procedures 2016 - 2022

University of Manitoba Winnipeg, Canada

Lecturer and Program Development Manager - Quality Improvement 2014 - 2016

Evergreen College Toronto, Canada

Quality Specialist - Quality Operation & Quality Control 2011 - 2012

Novartis – Ciba Vision Sterile Manufacturing Mississauga, Canada

Lab Technologist/Microbiologist - Quality Operation 2009 - 2011 Sanofi Pasteur Toronto, Canada

Education & Certification

Master of Science in Healthcare Quality, Safety and Risk Management 2016

Queen's University Kingston, Canada

Christopher Leadership Course 2014

McMaster University Hamilton, Canada

Certified Patient Safety Officer (CPSI) 2014

Canadian Patient Safety Institute Kingston, Canada

Quality Auditor Certificate 2014

American Society of Quality Toronto, Canada

Postgraduate Diploma in Quality Assurance and Regulatory Affairs 2013

Seneca College Toronto, Canada

Bachelor of Science in Biology, with honours 2011

Ryerson University Toronto, Canada

Initiatives and Non-peer Reviewed Work: 

1. Presentation – FACT, Health Canada, and Accreditation Canada Survey, Hamilton Health Sciences, 2015 
2. Master’s Thesis – The Effectiveness of Hand Hygiene Compliance Initiatives and its Impact on Infection Rates in Acute Healthcare Setting, Queens University, Master’s of Healthcare Quality, 2016 
3. Project – Onboarding Process for Physicians and Nurses, Hamilton Health Sciences, 2016 
4. Project – Document Management System, Hamilton Health Sciences, 2016
5. Project –Stem Cell and Bone Marrow Transplant Program Unit Expansion, Hamilton Health Sciences, 2017 
6. Project –Validation of autoclaves and sterilization equipment, Hamilton Health Sciences 2017 
7. Patient Safety incident categorization, Trillium Health Partners, 2018 
8. Interview – The Rewards of Quality Management, University of Manitoba Extended Education, 2018 
9. Interview – Online Courses Fit into your Life and Advance your Career, University of Manitoba Extended Education, 2018 
10. Project – Implementation of ThedaCare in healthcare, Trillium Health Partner, 2018
11. Project – Epic Health Information System implementation, Lakeridge Health, 2021
12. Presentation – Learning from Experience Lean in Healthcare, Lakeridge Health, 2021 
13. Project – Improving Portering Delays in Diagnostic Imaging and Emergency, Trillium Health Partners, 2017
14. Project – ECG/EKG Ordering Process Improvement, Lakeridge Health, 2021 Project – Staff Scheduling System Upgrade, Lakeridge Health, 2021
15. Presentation and Project – Implementation of Tiered Huddles, Lakeridge Health, 2021