Accreditation and Business Manager-Testing

About the role

Canadian Blood Services is looking for a Regular full-time Accreditation and Business Manager - Testing to join our dynamic Testing team in our Medical Affairs division.

The Testing team is responsible for supporting Canadian Blood Services (CBS) by delivering accurate and timely results on donors and products, ensuring the highest standards of safety and quality in our products and services.

In this role, you will be responsible for ensuring that the Testing laboratories adhere to accreditation standards in accordance with applicable regulations and standards, including Health Canada, College of American Pathologists (CAP) Foundation for the Accreditation of Cellular Therapy (FACT), Association for the Advancement of Blood & Biotherapies (AABB) and World Marrow Donor Associate (WMDA). You will also be responsible for the planning, management, development and implementation of CBS projects. You will coordinate the activities of all internal and external stakeholders and lead the various Project Team members to achieve project objectives in accordance with established cost and time parameters.

Formula for success

• Work with and coordinate the activities of the project start-up team, other CBS staff and, if required, external resources to develop and maintain the Project Plan; defines the deliverables, governance, staffing plan, roles and responsibilities, timelines, communications plan, training strategy, implementation strategy, regulatory approach, risk management plan, QA plan, costs, transition and close-out plans.
• Ensure appropriate review and approval of the Project Plan with key stakeholders and Steering Committee. Manage change to the project baseline plans throughout the life of the project.
• Oversee and plan for the preparation and execution of certification/accreditation processes stemming from applicable regulations and standards.
• Plan, implement, and execute all accreditation applications for unit. Ensure that responses to appropriate agencies are actioned appropriately. Stay abreast of any changes to standards and regulations and informs the program of required process changes.
• Develop, manage and monitor the project budget and schedule, ensuring the project is proceeding according to timelines, meeting targets and expectations, and adhering to established parameters.
• Coordinate with other CBS departments needed to carry out project activities, i.e., Facilities, Purchasing, Quality Assurance, Regulatory Affairs, and Information Services.
• Procure software, equipment and supplies as needed by the project, following CBS purchasing policies.
• Identify, assess and monitor project risks throughout the life of the project. Develop mitigation strategies against these risks and implements these strategies, if required.
• Identify issues requiring resolution, act as the subject matter expert and facilitate the analysis and resolution of these issues, and/or escalate the issue as required to the Project Director, Executive Director, Steering Committee or EMT as appropriate.
• Report project status to the Project Director, Project Sponsor, Steering Committee and/or other parties as required, on behalf of the Project Team. Carry forward all proposed changes in scope, schedule, budget and risk for review and approval.
• Develop and deliver training strategies and training and implementation plans.
• Recruit, train, oversee and direct project team members to effectively accomplish the goals and objectives of the project. Identify contractors and coordinate external resources as needed by the project.
• Oversee the assessment of certification/accreditation processes stemming from applicable regulations and standards across Testing division. Monitor changes/ revisions to regulations and standards working with the Manager, Planning and Continuous Improvement to close gaps and changes.
• Ensure employees comply with Work Instructions (WIs), regulations and/or standards, as applicable.
• Participate in external regulatory audits and assist in responding to audit observations. Document observation results and negotiate mutually acceptable corrective action plans. Conduct follow-up activities and verify effectiveness of implemented corrective actions.
• Support the Manager, Compliance and Resources with internal audits.

Desired education and skills

• Post-secondary level education, preferably a university degree in a related field, such as Medical Laboratory Technology (MLT), and experience with QA/Auditing.
• A minimum of 6 years of related experience. Evidence of ongoing professional development in quality assurance and leadership skills is required.
• Sound understanding of project management tools and techniques.
• Advanced verbal and written communications skills in English.
• Strong facilitation skills.
• Ability to analyze complex problems, interpret business needs, and develop integrated, innovative solutions.
• Knowledge of risk management concepts.
• General management and leadership experience.
• Experience with development of business cases and project plans.
• An equivalent combination of education, training and experience may be considered.

What we offer you

• 4 weeks' vacation
• Annual performance award up to 8%
• 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/days of the week.
• You will be expected to travel a couple of times per year, and as required.