Manager, Quality Control and Quality Assurance

Type: Permanent position
Location: Montreal
Department: Medical and Regulatory Affairs
Reports To: Senior Manager, Quality Control & Quality Assurance

Summary of Purpose:

This position will support activities related to Quality Control and Quality Assurance/Compliance for Otsuka Canada. Oversees product quality operations to ensure products meet the highest level of quality standards. Responsible for the Quality Management Systems and to ensure ongoing compliance to Good Manufacturing Practices within the organization.


  • Manage OCPI Drug Establishment License
  • Ensure regulatory inspection readiness, auditing activities and CAPA follow-up
  • Ensuring alignment and consistency of Canadian quality practices with other Otsuka regions
  • Supervising designated vendor for supporting quality and validation activities and ensure quality agreements are in place
  • Implement and monitor the quality strategy within his/her remit
  • Define quality audit programs and follow-up on their implementation
  • Responsible for approving supplier Master Batch Records
  • Ensure Good Storage and Distribution Practices for OCPI products
  • Responsible for Quality Assurance release of finished products to the Canadian Market
  • Ensure a continuous quality & compliance improvement mindset within his/her remit
  • Manage quality trends analysis, annual product quality review (APQR), deviations, change controls, API and Product specifications, Product Quality Complaints and other OCPI quality reports. Ensure corrective actions are completed
  • Responsible for appropriate Standard Operating Procedures (SOPs) to be developed/updated in order to ensure all product quality activities are performed in accordance with Canadian GMP and are aligned with Regional and Global SOPs
  • Report Safety Information, Product Quality Complaint and Customer Feedback as per training on current procedures
  • In addition, the Manager Quality Assurance & Quality Control will support the Management Representative with regards to the ISO 13485 Quality System
  • Acts as Senior Manager, Quality Assurance and Quality Control delegate, when required
  • Performs other related duties as required


Qualifications and Key Competencies:

  • B.Sc. in Health Sciences
  • Minimum 5-10 years of experience in Quality Assurance / Control in the pharmaceutical industry
  • Minimum 2-5 years of experience in a management position
  • Good knowledge of pharmaceutical processing techniques

  • Excellent knowledge of Canadian Good Manufacturing Practices and Regulations
  • Detail-oriented, thorough, and methodical
  • Strong interpersonal and organizational skills
  • Strong written and verbal communication skills

  • Computer literacy

  • Knowledge of Quality Management Software will be considered an asset
  • Excellent knowledge of spoken and written English and French
  • Well-organized, strong ability to manage several projects and priorities at the same time to meet tight deadlines
  • Analytical and problem solving skills

  • Strong customer-oriented attitude, team spirit and ability to establish effective relationships
  • Flexible and able to work in a fast-paced environment


Supervision of Others:


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