Assistant Director Quality Assurance - Winnipeg (Centennial), Manitoba Canada - 45776



JOB DESCRIPTION

Job #: 45776
Title: Assistant Director Quality Assurance
Job Location: Winnipeg (Centennial), Manitoba - Canada
Remote Job: No
Employment Type:
Salary: contact recruiter for details
Other Compensation: benefits
Employer Will Recruit From: Nationwide
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?


Expanding, busy company with room to grow

Company manufactures healthcare products and biologics, a very in demand industry

Close-knit teams and friendly atmosphere

 

JOB DESCRIPTION

Are you a Senior Quality Assurance Manager with a background in a highly regulated industry?

Do you hope to make a difference to ensure that the manufactured product adheres to specific quality guidelines and regulatory objectives? 

Our Western Canada client excels at producing very specialized healthcare and biological products, that meet the demanding needs of the marketplace.  Your senior management role is critical and would ensure that from a Quality standpoint the manufacturing operations are adhering to all Quality and Regulatory guidelines.

ROLE AND RESPONSIBILITIES:

  • Responsible for leading Quality and Validation teams.
  • Making decisions regarding quality processes, deviations, CAPA, and validation.
  • Ensure your validation strategy adheres to a master plan that promotes a complete review all protocols relating to the validated state of each particular system.
  • Work with users to identify continuous improvement needs and explain trade-offs associated with risk, quality and cost.
  • Manage compliance associated with current Good Manufacturing Practices (cGMP), FDA guidelines and corporate policies and procedures.  
  • Evaluate and explore challenging issues that would affect product safety and quality and keep senior management informed.
  • Manage FDA and customer inspections and oversee prompt replies to inspection findings.

 

QUALIFICATIONS

REQUIREMENTS: 

  • B.Sc. Engineering, Science, Pharmacy, Food plus minimum 10 years in biopharmaceutical or other highly regulated environments.
  • Prefer at least 5 years' management experience in Regulatory or Quality.
  • Strong knowledge and experience with QA and Validation.
  • Skilled at analyzing alternatives as well as researching. 
  • Excellent business judgement, English communication, interpersonal, problem solving, and consulting skills. 
  • Outstanding leadership and negotiating skills, good at mentoring, setting priorities, and gaining consensus.
  • In Winnipeg, or able to relocate across Canada. Must be Canadian citizen, PR, or hold valid work permit.

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