Director - Quality Assurance, Medical Services and Innovation

About the role

Canadian Blood Services is looking for a Regular full-time Director – Quality Assurance, Medical Services and Innovation to join our dynamic Office of VP Quality & Reg Affairs team in our Quality and Regulatory Affairs division.

The Office of VP Quality & Reg Affairs team is responsible for supporting Canadian Blood Services by providing high-level administrative and operational support to a Vice-President and their extended leadership team. Your keen eye for detail, strong judgment, and ability to manage complex schedules and communications will make you a vital member of the team.

In this role, you will be responsible for leading and maintaining the quality assurance program that ensures the safe, compliant, and high-performing delivery of Canadian Blood Services medical products and services. You will provide oversight and continual improvement of quality systems for regulated areas such as stem cells, organs and tissues, and donor and patient testing. You will apply expert leadership to uphold evolving regulatory requirements, accreditation standards, and industry best practices that protect donors and patients. You will also establish and advance the Quality Management System for new and emerging products and other strategic innovations. You will partner closely with operational, medical, and research teams to embed quality by design and implement efficient, risk-based processes from development through implementation. You will cultivate a high-performing quality culture, enables operational excellence, and ensures our growth in medical services continues to meet the highest standards of quality and safety.

Formula for success

• Leveraging your demonstrated knowledge and expertise, you will provide strong leadership, management and direction with respect to the development, operation and continuous improvement of the quality assurance program within medical service business lines.
• You will ensure all activities within the Quality Assurance (Medical Services and Innovation) group are aligned with Canadian Blood Services corporate objectives and priorities, and fully consider external developments, trends and quality and regulatory environments.
• Drawing on your service-oriented approach, you will maintain a current awareness of all activities within the Quality Assurance Medical Services group and the QRA Division as a whole, e.g. projects, strategic plans, etc. Provide direction, advice, guidance and assistance to the functional area Directors in regard to Quality Assurance related activities or requirements.
• Concentrating on your strong attention to detail, you will ensure that all activities with respect to quality assurance activities are in a state-of-control, complete and in compliance with applicable quality, regulatory and Canadian Blood Services requirements.
• You will be responsible for leading strategic planning activities for the Quality Assurance Medical Services group.
• Harnessing your strong risk management skills, you will develop and lead the Quality Management System for novel and emerging medical products and services to ensure safe, compliant, and efficient implementation. Design and implement risk-based quality processes that support development through to operational launch. Embed quality by design principles into research, innovation and product development activities.
• You will align quality standards with evolving regulatory and accreditation expectations for cellular therapies, genomics, and other related innovations.
• Focusing on your strong interpersonal skills, you will provide guidance and support regarding quality assurance requirements and activities to the different Canadian Blood Services Divisions, Groups or Departments.
• Leveraging your excellent organizational skills, you will ensure that all Divisions, Groups or Departments and/or sites are provided with all necessary information, guidance and tools required to effectively implement policies and procedures developed by the Quality Assurance Medical Services group.
• Using your ability to apply appropriate personnel management practices in the management of staff, you will recruit, evaluate and manage all employees of the Quality Assurance Medical Services group in the performance of their function. Provide direction in the development of staff through effective coaching and performance management.
• Utilizing your ability to lead and work collaboratively across diverse teams, you will provide leadership and direction in Canadian Blood Services corporate and QRA Division initiatives. Provide direction to Canadian Blood Services staff on quality assurance-related issues, requirements, policies or procedures.
• You will actively participate in developing the clinical trial capability within the organization.
• You will prepare, as required, department budgets and monitor expenditures to demonstrate continuous improvement in departmental efficiencies and to ensure financial targets are achieved.
• Drawing on your excellent communication and presentation skills, you will establish and maintain effective working relationships with various stakeholders and make presentations to the Board or Executive Management team as required.

Desired education and skills

• A University Degree in Life Science from a recognized academic institution, preferably at the graduate level, or an equivalent combination of education and experience.
• A minimum of 12 years of progressive senior leadership/managerial experience in the operations or quality within the blood system, in clinical healthcare delivery, pharmaceutical or Health Canada regulated industry.
• Sound knowledge and demonstrated expertise in quality assurance or quality compliance gained through managerial involvement or position in a health care, pharmaceutical or other manufacturing sector characterized by a stringent regulatory environment.
• Strong risk management skills including the applicability of risk management principles in a healthcare/manufacturing environment.
• Thorough understanding of concepts and principles of Quality System and Quality Assurance.
• Thorough understanding of the application of Good Manufacturing Practices as regulated by Health Canada and the United States Food and Drug Administration.
• Demonstrated strong writing and communication skills and ability to communicate effectively at multiple levels, including with regulatory agencies, EMT, the Board, peers, and direct reports.

What we offer you

• 4 weeks' vacation
• Annual performance award up to 12%
• Comprehensive group health, dental and vision benefits for you and your family
• Defined benefit pension plan
• Employee discounts, wellness program, professional resources

What you can expect

• This role will work in a hybrid environment with requirements to be onsite at Canadian Blood Services location 40% of the time/2 days of the week.
• You may be required to travel 20% of the time for this role.