Manager, Quality Assurance & Quality Control

Type: Permanent - Full time
Location: Montreal Head Office
Department: Medical and Regulatory Affairs
Reports To: Associate Director, Quality Assurance & Pharmacovigilance

Summary of Purpose:
This position will support activities related to Quality Assurance/Compliance and Quality Control 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.

Responsibilities:
• 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

Qualifications and Key Competencies:
• B.Sc. in Health Sciences
• Min ten (10) years of experience in Quality Assurance / Control in the pharmaceutical industry
• Min five (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:
None