Resume

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ANDREW MILROY

Toronto, Canada – andrewpmilroy@gmail.com

CAREER SUMMARY

Experienced healthcare professional and systems thinker, with expertise in the development and management of Quality Management Systems, quality assurance, performance and process improvement, auditing, capacity building and training. Certified Lean Six Sigma Black Belt with over 10 years of combined experience managing Quality Management Systems, working on quality and process improvement projects, and supporting complex regional projects within healthcare, the clinical research industry, and international development.


HIGHLIGHTS 

  • Extensive knowledge, and experience with Lean Six Sigma (certified Lean Six Sigma Black Belt) and Project Management Methodologies
  • 9+ years of experience in executing improvement methodologies and tools to continuously deliver changes to ensure the best future states were built
  • 7+ years of experience in managing Quality Management Systems within healthcare and the clinical research industry to ensure compliance with regulatory and accreditation standards
  • Extensive knowledge, and experience with Lean Six Sigma (DMAIC/PDSA, Root Cause Analysis, Process and Value Stream Mapping, FMEA) from over 50+ Quality Improvement Projects
  • Experienced Auditor with 150+ Internal Audits, 550+ IPAC and Mobility Audits, 11 External Audits (Inspection, Accreditation, Initial Supplier Evaluation, Annual), 15 Supplier Audits
  • Investigated 250+ Quality related incidences since 2018 providing corrective actions while assigning Risk Level, assessing for systemic issues, and reporting to Senior Management
  • Proven project management skills in project planning, project progress monitoring and implementation to meet quality improvement requirements
  • Advanced conceptual and analytical skills, proven ability in collecting and analyzing data, providing reports and recommendations for successful quality improvement
  • Superior problem-solving skills in dealing with various circumstances and navigating complex issues in a calm and professional manner
  • Excellent written and verbal communication skills with presentation skills developed through Toastmasters International
  • Management of staff including staff from implementing partner organizations, project coordinators, and expert advisors
  • Developed and maintained strategic partnerships for UN Millennium Campaign Asia and the Pacific and built and maintained relationships for UNDP Asia and the Pacific Capacity Development team and MP Rob Oliphant
  • Strong background in ethics with a Specialist B.A. (Hons) in Bioethics and an M.A. (Distinction) in Applied Ethics with academic knowledge of international and national research ethics regulations and standards

PROFESSIONAL EXPERIENCE

Quality Specialist

Quality Coordinator (promoted May 1, 2021)

Eye Bank of Canada (Ontario Division) (2017 – Present)

Toronto, Canada

The Eye Bank of Canada (Ontario Division) is the largest eye bank in Canada and, as of July 2015, became part of Kensington Health. The role of the Eye Bank is to collect, process and distribute donated human eyes and tissue for sight-saving transplants.

Additional Responsibilities under Quality Specialist position

  • Lead (Eye Bank) and assist (other ambulatory entities ) with regulatory/accreditation body inspection preparation, planning, and execution, acting as key contact during third party or regulatory/accreditation body audits.
  • Collaborate with clinical programs to implement recommendations that improve patient and staff safety by completing safety reviews, data, identifying trends, and implementing recommendations
  • Research, analyze, develop, and disseminate new knowledge regarding staff/patient care and safety quality improvement, risk reduction
  • Technologies, equipment, and process risk prevention (e.g. prevent equipment failure )
  • Lead patient care quality improvement and enhancement initiatives (e.g. patient satisfaction, safety, patient care outcomes) to increase operational efficiency and reliability, and reduce clinical and operational risks and cost
  • Lead preparation and review of mandated reporting requirements that meet governmental and organizational performance objectives (TGLN reports)
  • Recommend strategic priorities for direct supervisor approval (e.g. data analysis to define areas for improvement)
  • Project management responsibilities related to quality needs as identified by the ambulatory entities
  • Assist ambulatory teams with collection, interpretation, analysis and presentation of performance data as required
  • Manage tracking initiatives and strategies to facilitate Quality Management System assessments and sustain quality and process improvement initiatives.

Original Responsibilities

  • Responsible for the implementation, management, and assessment of the Quality Management System ensuring compliance with all EBAA medical and Accreditation Standards, Provincial and Federal regulations and Standards
  • Develop, implement and maintain Quality Management System documentation in compliance with Health Canada, EBAA and Eye Bank of Canada – Ontario Division policy requirements
  • Produce written reports and make presentations
  • Write, review, and implement policies in compliance with all applicable regulatory agency requirements (EBAA, Health Canada etc.)
  • Lead the preventative action, corrective action, and continuous improvement processes to prevent Quality Management System failures, correct non-conformances, and ensure effective and lean processes
  • Work with the Manager to determine and facilitate quality improvement projects
  • Ensure complete documentation and formal conclusion of all event reporting such as accident, error, adverse event and recall
  • Ensure that validations/verification of new and existing equipment, supplies, reagents, and instruments pass regulatory standards, and is safe for use
  • Review, evaluate and sign off equipment monitoring records for maintenance within specified tolerance limits to assure tissue safety and compliance with regulations, standards (i.e. Health Canada, CSA, EBAA), and Eye Bank of Canada – Ontario Division policies
  • Ensure validation, verification, and maintenance of processes, equipment, and supplies is performed and documented in accordance with policies
  • Organize and conduct internal and external audits to ensure that the Quality Management System is implemented as written and is effective including identifying and investigating trends, applying root cause analysis, providing feedback and recommendations to the management team, and ensuring corrective actions are undertaken to address nonconformities found or opportunities for improvement

Manager, Human Research Protection Program and Clinical Quality Assurance

Merita CQA (2014-2016)

Montreal, Canada

Merita CQA Inc. provides expert quality assurance support services, training for clinical researchers, investigators and study coordinators, and all services related to the establishment and ongoing management of Data Safety Monitoring Boards.

  • Managed the audit lifecycle for vendor, internal, and third-party audits
  • Developed audit plans, reports, and schedules for all audits and kept organized records
  • Analyzed data to inform Corrective and Preventive Action plans and recommendations
  • Trained and facilitated knowledge exchange of staff and clients
  • Analyzed, identified and developed training strategies and materials
  • Maintained and developed training records for all staff members
  • Maintained HRPP accreditation for the ethica Clinical Research Inc. group of companies
  • Responsible for monitoring new government directives, changes to industry regulations, and identification of best practices
  • Maintained and updated corporate Standard Operating Procedures (SOPs)
  • Developed training package for Principal Investigators and other research staff which included modules on key topics and a set of SOPs for guidance
  • Developed project Gantt charts, budgets, and vendor selection matrix
  • Managed Project Coordinator who assisted in the development of an online training program targeting Principal Investigators and Clinical Research staff
  • Led company committee on response plan for emergency situations
  • Achievement: Successfully managed a Third-Party Audit which led to zero official observations and resulted in the client being awarded a contract worth over $1 million.

Program Coordinator 

Clinical Trials Ontario (2013 – 2014)

Toronto, Canada

Clinical Trials Ontario (CTO) is an independent not-for-profit organization established with support from the Government of Ontario. Their mandate is to work collaboratively with the clinical trials community, the public and strategic partners to improve Ontario’s clinical trials environment and attract clinical trial investment to the province while supporting the highest ethical and quality standards.

  • Coordinating the development of the Streamlined Research Ethics Review System
  • Developed REB Qualification Manual including Qualification Checklist used for qualifying REBs under the Qualification Program
  • Drafted Standard Operating Procedures and communication pieces to support the processes involved in the Qualification Program
  • Provided support to CTO advisory groups including drafting of accurate meeting notes which captured key discussions, decisions, and action points, and disseminated notes in a timely manner.
  • Conducted literature search and review of articles on clinical trial participant engagement and recruitment and synthesized findings for presentations on the topic
  • Achievement: Instrumental in developing the process for qualification of REBs in Ontario to streamline administrative processes and reduce clinical trial start-up times.

Administrative Assistant 

Canadian Association of Research Ethics Boards (2014)

Toronto, Canada

The Canadian Association of Research Ethics Boards (CAREB-ACCER) is a grassroots national membership organization intended to represent the interests of all Canadian Research Ethics Boards (REBs) and to reflect REB perspectives and concerns.

  • Worked directly with conference attendees using the online system to register, answering questions and resolving issues related to troubleshooting of site functionality and conference logistics, escalating issues when needed
  • Acted as a liaison between conference attendees using the online registration system and CAREB board members
  • Achievement: Successfully resolved conference attendees IT and registration issues with tactful, professional, courteous, customer service oriented and centric approach leading successful conference implementation.

Research Assistant 

Mount Sinai Hospital – Geriatrics Department (2012 – 2013)

Toronto, Canada

Mount Sinai Hospital, Joseph and Wolf Lebovic Complex which is part of Sinai Health System, is an internationally recognized 442-bed acute care academic health sciences centre affiliated with the University of Toronto.

  • Conducted audits to benchmark, track, and evaluate an educational intervention implemented in 14 hospitals across Ontario
  • Managed, coordinated, and implemented the data collection phase of a clinical research project targeting hospital staff aimed at reducing functional decline and promoting mobility among elderly patients
  • Ensured audits were managed and completed according to agreed timelines and up to quality standards with strong attention to detail when performing data entry
  • Conducted a literature search on the ethics of home-based primary care and synthesized findings into a chapter for toolkit
  • Achievement: Played a vital role in the collection and entry of research data for use in reports and presentations

Head of Youth and Civil Society 

Swechha – We for Change Foundation (2011)

Delhi, India

Swechha is a youth-run, youth-led NGO operating out of Delhi, India focusing on the environment and civil society engagement

  • Managed a team of youth on individual and group basis
  • Supervised program planning, development, reporting, implementation, assessment, and evaluation
  • Insured that program staff followed through on all planning, budgetary, scheduling and implementation of tasks
  • Actively researched funding and development for reported programs
  • Primary collaborative partner with Director, Executive Director and other designated collaborating partners

 Special Assistant 

Member of Parliament, Don Valley West (2010 – 2011)

Toronto, Canada

The Member of Parliament I served, MP Rob Oliphant, was the Multiculturalism Critic for the Liberal Party of Canada and responsible for the most multicultural constituency base in Canada with offices in Ottawa and Toronto.

  • Provided program support for MP constituency office, solving constituent problems and concerns independently through coordination with Government agencies
  • Liaised with representatives from Government and Civil Society Organizations and supported development of stakeholder relationships between MPs Constituency Office and constituents
  • Contributed to production of quarterly communication releases including press releases along with drafting correspondence on behalf of MP including letters of support
  • Tracked progress of constituent cases and used sound judgment in finding resolutions to problems
  • Organized briefing material for the MP on issues of local concern and as directed, advised MP on possible alternative stances on issues of local concern
  • Maintained constituent database with up-to-date case information
  • Performed administrative duties including inter-governmental office coordination relating to casework and public relations relating largely to citizenship and immigration
  • Organized briefing material for the MP on issues of local concern and as directed, advised MP on possible alternatives stances on issues of local concern
  • Addressed media enquiries and requests as needed
  • Achievement: Built and maintained important and close relationships with constituents, businesses, and local organizations in the Don Valley West riding

Project Coordinator 

United Nations Millennium Campaign – Asia and the Pacific (2009 – 2010)

Bangkok, Thailand

The UN Millennium Campaign is a global campaign which supports and inspires peoples from around the world to take action in support of achieving the Millennium Development Goals.

  • Managed a project portfolio consisting of 5 countries as project lead reporting to a Project Management Team comprised of the Director and senior staff in New York
  • Monitored, documented, and evaluated progress according to the project timeline and took appropriate measures to close gaps capturing all project information in a final assessment
  • Developed and implemented project activities and budget, managing procurement processes relating to request for bids, proposals, and review of invoices/budgetary amounts and reviewed transfer of funds to contracted organizations in the field
  • Maintained the overall work plan and schedule for pilot implementation, supporting Implementing Partners with necessary materials and logistical information and advice
  • Mapped and tracked existing partnerships and ongoing initiatives for potential partnerships and participation opportunities with the implementation
  • Worked in consultation with communication colleagues in New York and National Offices to ensure information and data provided was sufficiently aligned with global office
  • Drafted and edited news briefs, website contributions and other material for public use, briefing materials, articles, and op-eds for National Offices and other senior staff
  • Developed the online communities web space including design, testing, and continual improvement
  • Provided online moderation and facilitation of community posts ensuring appropriate discussions and comments being displayed and ensuring vibrant online activity while increasing membership
  • Conducted extensive research on the topic of online youth communities and campaigning in Asia and the Pacific and wrote a primer on the subject to share best practices
  • Achievement: Effectively coordinated piloting in the Philippines, India, and Indonesia reaching national coverage in the Hindu, India’s third-largest newspaper, and INQUIRER a leading newspaper in the Philippines

Junior Professional Consultant 

United Nations Development Programme (CANADEM) (2008 – 2009)

Bangkok, Thailand

The United Nations’ global development network. It advocates for change and connects countries to knowledge, experience, and resources to help people build a better life.

  • Provided consulting and program support services to the Capacity Development teams Pro-Poor Public-Private Partnerships (PPP) program
  • Engaged with networks of institutions and individuals involved in Pro-Poor Public-Private Partnerships (PPPs) for Service Delivery to promote the sharing of tools, knowledge, and experiences
  • Developed a Knowledge Product that depicted and shared experiences of selected Pro-Poor Public-Private Partnerships for Service Delivery from country partners in Asia
  • Contributed to best practice and lessons learned documents on sustainable Pro-Poor PPPs for local service delivery to be shared with partners in the region
  • Developed the 2009 UNDP Capacity Development Team’s Work Plan
  • Developed a proposal for integrating local basic services/infrastructure delivery related issues into regional ongoing and forthcoming anti-corruption initiatives
  • Developed capacity development tools for use by local-level actors involved in Pro-Poor Public-Private Partnerships
  • Achievement: Introduced a Brown Bag Lunch Series for educational training of UNDP staff.

Research Assistant 

Hospital for Sick Children (Summer of 2004 & 2005)

Toronto, Canada

Recognized as one of the world’s foremost paediatric health-care institutions and is Canada’s leading centre dedicated to advancing children’s health through the integration of patient care, research, and education.

  • Conducted qualitative research on the use of Complementary and Alternative Healthcare for Children (CAHC)
  • Collected, organized, analyzed, and presented information on the topic of Complementary and Alternative Healthcare Use on Children
  • Drafted educational materials including a poster for display during an Ethics Week and trained hospital staff through and Every Day Ethics seminar
  • Wrote a formal research paper indicating the current development in Complementary and Alternative Health Care policy and procedures for children and provided policy advice
  • Achievement: Effectively analyzed research data and synthesized research into a final report to inform the development of policy

VOLUNTEER EXPERIENCE

  • Director, Board of Directors – Canadian Mental Health Association Toronto Branch (Toronto, Canada); October 2022 – Present
    • Member – Quality Improvement Committee (November 2022 – Present)
  • Rotarian, Toronto Twilight Rotary Club – Rotary International (Toronto, Canada); February 2012 – November 2014 and July 2018 – June 2022
    • President (2020/2021 Rotary Year)
    • Vice-President (2019/2020 Rotary Year)
    • Service Director (2018/2019 Rotary Year)
    • Sergeant-at-Arms (2012/2013 Rotary Year)
    • Playing an active role in the community through volunteering time with charitable organizations
    • HIV/AIDS Poker Walk Team Captain
  • Member, Quality Assurance Committee, Eye Bank Association of America (Toronto, Canada); July 2020 – June 2022
    • Supporting the work of the committee by providing input and expertise.
  • Representative, We Respect All People Committee, Kensington Health (Toronto, Canada); July 2019 – June 2020.
  • Alumni Volunteer, Backpack to Briefcase (b2B) for the University of Toronto (Toronto, Canada); August 2017 – August 2018
    • Sharing knowledge with students on careers after graduation during Networking Events, Workshops, Mentorship Meals, and 1-on-1 as a Mentor to a student.
  • Volunteer Fund Developer, Kenya Association for Maternal & Neonatal Health – Maternal, Newborn, and Child Health Dispensary project (Nairobi, Kenya); November 2017 – May 2018
    •  Drafting funding proposal to set up 21 MNCH health dispensaries in Kenya by end of 2021
  • Volunteer, University Health Network (Toronto, Canada); June 2017 – September 2017
    • Administered survey’s on the use, storage, and disposal of prescription opioid pain medication, and a patient as the observer hand sanitization survey.
  • Chair, Canadian Association of Research Ethics Boards – Webinar Development Sub-Committee of the Professional Development Committee (Montreal, Quebec); July 2016 – March 2017
    • Directed the development of a Webinar series aimed at educating Research Ethics Board members and staff on contemporary research ethics issues
  • Member, Canadian Association of Research Ethics Boards – Professional Development Committee (Montreal, Quebec); February 2015 – March 2017
    • As part of the Webinar Implementation Subcommittee have worked on the “CAREB Research Ethics Professional Development Webinars”
  • Ethicist, University Health Network Research Ethics Board – Oncology Research (Toronto, Canada); November 2012 – November 2014
    • Reviewed clinical trial applications for adherence to ethical principles and regulations governing research in Ontario
    • Provided position papers on systemic ethical issues such as sharing of trial results to participants
  • Volunteer, Canadian Bioethics Society (Toronto, Canada); December 2012 – November 2014
    • Developed a database of organizations in Canada offering grants for fundraising purposes
    • Performed an audit of yearly financial records
  • Campaign Canvasser, Liberal Party of Canada (Toronto, Canada); March 2011 – May 2011
    • Worked towards the re-election of Robert Oliphant through door-to-door and phone canvassing
    • Provided advisory services for campaign debates through development of a brief
  • Don Valley West Federal Liberal Riding Association, Executive Committee – Policy (Toronto, Canada); January 2010 – May 2011
    • Supported the association through policy inputs and formulation of Federal recommendations regarding policy matters including, Multiculturalism, Employment, and Environment
    • Participated as voting member during the 2011 LPC (O) Policy Prioritizing Meeting
    • Wrote white papers for high-level dissemination on key policy issues
  • Committee Member, Leaside Gardens Management Board – Expansion Committee (Toronto, Canada); December 2010 – May 2011
    • Supported the fundraising effort towards 2.5 million dollars through means of providing mailing list information and time
    • Drafted writing public correspondence and liaised with both community leaders and those from business
  • Member, Interagency Regional Youth Group – United Nations Economic and Social Commission for Asia and the Pacific (Bangkok, Thailand); December 2009 – July 2010
    • Developed IRYG strategy papers for International Youth Day as member of the sub-group, International Youth Year Task Force
    • Provided UNMC input towards establishing a clear objective of the group and structured duties and responsibilities for the 2010 International Year of Youth: Dialogue and Mutual Understanding
    • Substantive review of Draft Declaration for World Youth Conference Mexico 2010
    • Delivered presentation during 3rd Interagency Meeting on Youth Programme entitled “Engaging with Youth via Web 2.0 Technology”
  • Deputy Zone Warden, United Nations Department of Safety and Security – Zone 2 Dusit and Bang Sue (Bangkok, Thailand); October 2008 – August 2010
    • Monitored media sources and UN Security channels for up-to-date information regarding political unrest and remained on standby if needed to act as a channel of communications between Designated Officials and staff
  • Vice – President, International Student Union of Trondheim, International Student Union (Trondheim, Norway); January 2008 – July 2008
    • Provided leadership and direction for the ISU, responsible for over 1,500 international students
    • Produced weekly meeting reports to disseminate information regarding unified and agreed upon objectives to board members
    • Worked within several teams as a supervisor on concurrent projects to assist and ensure programs were on schedule
  • Member, Undergraduate Initiative of the Joint Centre for Bioethics, (Toronto, Canada); September 2002 – November 2005

EDUCATION

Master of Arts (Distinction) – Applied Ethics: Social and Political (2008)

Norwegian University of Science and Technology

Bachelor of Arts (Hon) – Specialist in Bioethics (2005)

University of Toronto

CERTIFICATIONS

Certificate Course on Quality Improvement and Patient Safety (2022)

Centre for Quality Improvement and Patient Safety (U of T Faculty of Medicine)

Patient Safety Specialization (2018)

Coursera – John Hopkins Medicine: Armstrong Institute for Patient Safety and Quality

Lean Six Sigma: Black Belt (2017)

Six Sigma Global Institute (IASSC Accredited Training Institute)

Lean Six Sigma: Green Belt (2016)

Six Sigma Global Institute (IASSC Accredited Training Institute)

AWARDS

Erasmus Mundus Scholarship (21,000 €) by the European Commission for academic success and experience in the field of ethics – June 2007

TRAINING

  • Eye Bank Association of America Annual Meeting – Online June 18 – 20, 2020
  • Failure Mode and Effects Analysis (FMEA) – Managing Risk – Course by ASQ Online Learning November 29, 2019
  • Root Cause Analysis – Course by ASQ Online Learning November 29, 2019
  • Eight Wastes – Course by ASQ Online Learning November 29, 2019
  • AATB Online Auditor Course – Online Training Course by AATB May 18, 2019
  • An Introduction to Lean Methodology in Eye Banking – Webinar by Greg Olson Iowa Lions Eye Bank EyeLEARN April 1, 2019
  • Quality Assurance – Seminar by EBAA, San Antonio, Texas September 27 – 28, 2018
  • Measuring & Managing Customer Satisfaction – Course by ASQ, Quality WBT Centre for Education January 20, 2018
  • Write Professional Emails in English: DOs and DON’Ts in Professional Email – Webinar by Gerry Landers, Georgia Institute of Technology January 13, 2018
  • Worker Health and Safety Awareness in 4 Steps – Training Module by Ministry of Labour September 27, 2017
  • An Introduction to the Model for Improvement – Webinar by Robert Lloyd, PhD, Institute for Healthcare Improvement August 4, 2017
  • Business Foundations (Finance, Accounting Fundamentals, Microeconomics, Marketing Fundamentals, One-Variable Statistics, Two-Variable Statistics) – Pedago LLC June 10 – July 8, 2017
  • Leading and Working in Teams – Course by Amy Edmondson, Harvard Business School February 8, 2017
  • Lean Six Sigma Fundamentals – Course by Steven Brown, Arizona University October 24, 2016
  • FDA CDRH/BIMO Update – Webinar June 15, 2016
  • Blueprint to Building Better Training Programs – Webinar January 20, 2016
  • Auditing Clinical Research Studies: An Overview For Assessing GCP Compliance – Webinar December 14, 2015
  • How FDA Trains Its Investigators to Review CAPA, and What You Can do to Prepare – Webinar November 5, 2015
  • Society of Quality Assurance: GCP – Module 1: Primary Principles of GCP – Online Module October 16, 2015
  • Canadian Chapter of the Society of Quality Assurance – CCSQA Annual Meeting October 1 – 2, 2015
  • Santé et Services sociaux Quebec: Tutorial in Research Ethics (Level 1, 2, and 3) – Online Modules November 19 – 20, 2014
  • Communicating Clinical Trial Results to Study Volunteers: The Critical Role of Post-trial Communication in Engaging Patients as Partners in Clinical Research (Best Practices) – Webinar June 23, 2014
  • The Site’s Realities and Its Impact on Barriers to Patient Recruitment and Retention – Webinar June 11, 2014
  • Central IRBs: Models, Logistics, and Implications – Webinar April 15, 2014
  • Canadian Association of Research Ethics Boards Ontario 2013 Conference – December 6, 2014
  • Sponsor’s Perspective on Advancing the Use of Central IRBs for Multicentre Clinical Trials in the United States – Webinar November 14, 2013
  • Gender Issues in Clinical Trials: Ethical, Regulatory and Practical Considerations – Webinar October 7, 2013
  • Tri-Council Policy Statement 2 (TCPS2) CORE Tutorial – February 18, 2013
  • Toastmasters International – November 2006 – September 2007

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