Government, Regulatory and Code, Healthcare, Quality, Quality Engineering
Join Canada’s Lifeline!
We are currently seeking a Manager, Quality Assurance to join our Quality and Regulatory Affairs teamin Ottawa.
Be part of a dynamic, innovative, collaborative, diverse and caring organization committed to saving and improving the lives of Canadians. We are the connection between the sincere generosity of donors, and the heartfelt appreciation of recipients. Thousands of Canadians depend on our programs every day for reliable access to safe blood, plasma, stem cells, organs and tissues.
This position ensures that the safety, quality, identity, purity, potency, and accessibility requirements of all products and services offered by Canadian Blood Services are met. You must have a thorough understanding of, applicable Good Manufacturing Practices, and Blood Regulations as defined by Health Canada, CSA Blood and Blood Component Standards, as well as relevant Cell, Tissues and Organs (CTO) regulations and standards and the theory and application of quality system elements to the products and services provided by Canadian Blood Services.
Under the direction of the Associate Director, you will be responsible for management, execution and evaluation of established quality assurance activities, ensuring effective and efficient people and process management, in an environment which fully recognizes the benefits of operating in accordance with quality principles.
You will lead in the development of your team by understanding the collaborative effort required within a team environment and optimizing the team diversity to make the team successful in meeting or exceeding the quality assurance objectives. You will use performance-based measurements to align the objectives of the team and the individuals to meet the strategic objectives of the Q&RA division and CBS.
You will also be responsible for consulting and collaborating with various internal and external stakeholders to ensure that the Quality program, procedures and support tools meet user, business and regulatory requirements.
Are you ready to embark on a meaningful and inspiring journey, where what you do matters? Be part of Canada’s lifeline. Because we can all be the reason, the connection, that keeps Canadians living.
Effectively and efficiently manage the Quality Assurance team and budget to ensure effective and efficient use of resources in a positive working environment in which the team feel empowered, challenged and engaged.
Ensures the monitoring of process performance and product quality to ensure a state of control and compliance to requirements/specifications is maintained.
Ensures a state of control and compliance with requirements and specifications is achieved.
Leads or participates in initiatives that improve processes and services including the development, implementation, monitoring and improvement.
Develops and maintains strong, effective day to day working relationships with all CBS staff.
May serve as designate for the Associate Director, Quality Assurance, in the absence of the incumbent.
Education, Training and Experience:
Post-secondary level science-based education such as a bachelor’s degree in a related discipline from a recognized academic institution or equivalent professional education and experience.
A minimum of six years of progressive experience in pharmaceutical, medical device or biological manufacturing following Good Manufacturing Practices or in-depth knowledge of a comparable quality management system is required.
A minimum of 3 years’ experience in the quality assurance function of a pharmaceutical manufacturer, medical device or biological manufacturer following Good Manufacturing Practices.
A minimum of six years of progressive management experience.
Certification or formalized education in Quality Management Systems is required.
Demonstrated Skills and Abilities:
Demonstrated knowledge of Quality Management System elements is required.
Ability to work with a team of high-performance professionals.
Demonstrated analytical, problem-solving and decision-making skills are required.
Demonstrated sound organizational and management skills are required.
Proven effective interpersonal, facilitation, presentation, written and verbal communications skills.
Demonstrated policy and procedures development abilities.
Strong communication skills in English are essential.
Proficiency with Microsoft Office and other known software packages.
Familiarity with electronic budget preparation and monitoring.
Position is required to be on call and to travel domestically.
Additional Salary Information: Canadian Blood Services offers a generous total rewards package including:
4 Weeks Vacation
Group Health & Dental Benefits
Choice of Defined Contribution or Defined Benefit Pension Plan
Internal Number: 9368-239
About Canadian Blood Services
Our story began 20 years ago. The next chapter is now underway. It’s a story about the power of connections: from blood and plasma, to stem cells, and organs and tissues. It's a story between donors, recipients and all the people that bring them together. It’s about the power of connections to keep Canadians living. It's about the something we can do today, knowing that because of us, someone else is waking up healthy tomorrow. Trusting that we can all be part of the connection that keeps the story going: together, we are Canada's Lifeline.