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Director Quality Assurance

Date: Jun 23, 2022

Location: Ottawa, ON, CA

Company: BWX Technologies

BWXT Medical Ltd. provides its customers, who conduct life-saving medical procedures for patients around the world, the benefit of decades of experience in the development, manufacturing, packaging and delivery of medical isotopes and radiopharmaceuticals. Headquartered in Kanata, Ontario, BWXT Medical Ltd. employs over 300 highly-skilled people in Kanata and Vancouver, British Columbia. BWXT Medical Ltd. is part of the BWXT nuclear power segment (NPG) of BWX Technologies, Inc.

Job Purpose

  • This is a leadership position responsible for the development, implementation, and administration of comprehensive quality assurance programs, and Good Manufacturing Practices.

 

Job Structure and Communications

  • Reports to President BWXT Medical.
  • Responsible for leading QA group to ensure corporate quality systems and external regulation compliance. The Director, QA also anticipates the need for changes to quality assurance practices, and makes those changes effective in a timely manner. Directs the Quality Control, Regulatory Affairs and Document Management teams to meet and exceed, where possible, the divisional goals.

 

Accountabilities

  • Within the general framework of the quality objectives, legal requirements for product approval and licensing, and the strategic plans of the Company, is responsible for and has the authority to accomplish the following duties in the Medical Isotope business unit, through direct involvement or the leadership of team members.
  • Ensure the efficient and cost effective operation of the Quality Assurance in order to meet, and exceed where possible, all customer expectations with respect to quality of products and services.
  • Maintain the Quality System within the Medical Isotope business unit.
  • Functions as the Management Representative, according to the requirements of ISO13485:2016 and as defined in the Quality Manual, QSF-00.
  • Administer The Internal Audit system to ensure company-wide compliance with the Regulations, standards, QA Manual and related procedures.
  • Create, implement and maintain all required QA systems to ensure compliance Coordinate the Management review team meetings, including preparation of Quality System Reports that summarize the status of Company Quality System.
  • Ensure the appropriate registrations for new or changing products occur. This includes, but is not limited to, FDA, Health Canada, EMEA regulations and guidance, ISO 9001, ISO 13485.
  •  Direct the creation, monitoring and maintenance of cGMP systems as required for manufacture of parenteral drug, API and Medical Device products. Provide sufficient knowledgeable QA resources for product and process development initiatives allowing for successful product registrations.
  •  Manage QA education programs including, but not limited to, GMP and specific education programs as needed for training. 
  • Co-ordinate external regulatory audits through organization, preparation, training and coaching of staff from all areas of the company that are involved. Lead regulatory, registrar and notified body audits. Manage all outcomes of regulatory audits.
  •  Establishes the duties and responsibilities of direct reports and delegates authority and responsibility as deemed appropriate.
  • Develop objectives and strategies to meet the overall objectives of the Business unit. Directs the department to ensure Medical Isotopes business objectives are achieved.

 

Knowledge and Experience

  • Normally University Honours Degree in Science (life sciences or chemistry) plus 10 to 12 years' experience working in quality assurance or other relevant environment, which is subject to external regulation.
  • The work requires a sound understanding of quality assurance issues in the context of external regulation.
  •  Must possess ability to manage a professional group, and influence senior management and professionals within the organization.
  •  The incumbent must have the analytical ability to judge the adequacy of quality assurance and to participate in the resolution of problems.
  •  The incumbent must have the ability to determine and defend product disposition when the disposition decision is questioned internally or externally by the customer or regulator.

BWXT Medical Ltd. embraces diversity of thought, values individuality, encourages new perspectives and provides equal opportunity in employment for all qualified employees and applicants without regard to race, national or ethnic origin, colour, religion, age, sex, sexual orientation, marital status, family status, disability, a conviction for which a pardon has been granted or a record suspended or any other category protected by federal law.


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