Quality Assurance Manager- Canada

Job Description

2 year contract – possible c2h

Location: Canada – Toronto (3 days in office)

The Quality Assurance Manager, Canada, holds primary responsibility and accountability for providing comprehensive quality oversight of all product distribution activities within Canada. This pivotal role specifically manages GMP release of products, ensuring strict adherence to SOPs, internal policies, and relevant industry guidance.

This position requires extensive collaboration and interaction with both internal cross-functional teams at and the external network of Contract Manufacturing Organizations and contract laboratories. The core objective is to ensure that all activities related to product quality and distribution in Canada fully comply with cGMP / GDP. Furthermore, this role is crucial in ensuring that all necessary quality systems are robustly established and consistently maintained to support Canadian operations.

Responsibilities

• The responsibilities of this position may include, but are not limited to, the following:
• Ensure quality and compliance frameworks, guidance, and Canadian quality systems are in place to keep the products current with industry and health authority regulatory expectations, as well as QMS for products throughout the life cycle development.
• Ensure that Canadian quality system documents, SOPs, Quality Agreements, SMFs, are compliant, up to date and accurate.
• Write and review Quality Technical Agreements (TQAs) with CMO, suppliers and Customer.
• Manage the release and Batch certification of all the Canada Commercial products for sale to Canadian Market.
• Support the maintenance of the Canada Drug Establishment License.
• Support internal audits to ensure ongoing compliance and continued improvement.
• Support in managing the self-inspection audit program, including preparation of annual schedule and executing audit plans
• Support external audits of contract organizations, including Canadian warehouses and Canadian laboratories.
• Work closely with the cross-functional partners to prepare for and support Health Canada inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
• Ensure that service providers, facilities, personnel, procedures, and practices are critically evaluated to consistently meet regulatory requirements.
• Review Compliance documentation; Annual Stability Reports, Process Validation Documents, Unique ID certification and Alternate Retention Sample Certification
• Works collaboratively with the team in Quality, Regulatory Affairs, Supply Chain, Manufacturing and Commercial organizations to effectively execute tasks and to participate in projects representing the Canada affiliate
• Work with cross-functional partners for the risk identification, resolution of issues, OOS, and risk /gap mitigation
• Monitoring and reporting quality performance indicators to management and taking leadership in the performance of Quality Management Reviews
• Ensure all events, CAPA and Changes are appropriately documented and in line with the principle of Risk Management.
• Ensure that initial and continuous training programs are implemented and maintained for relevant Canada employees.
• Perform products Recall in Canada and conduct annual Mock Recall as per Global schedule
• Ensure that relevant customer complaints are dealt with effectively
• Provide global support as a Subject Matter Expert for many Global projects
• Approve any subcontracted activities which may impact GDP
• Ensure that any additional requirements imposed on certain products by national law are adhered to
• Ensure adherence to the quality roles and responsibilities stipulated within the most recent Pharmacovigilance Agreement executed by Inc Boston and Canada.
• The successful candidate will also provide flexible support to the hiring manager on various ad-hoc tasks and special projects as needed, contributing to the broader team objectives.
  
  

Knowledge And Skills

• Expertise in GxP Regulations, demonstrated working knowledge and practical application of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). This includes deep familiarity with US, Canadian, and international/global regulatory requirements and associated guidance documents and standards across diverse modalities (e.g., small molecule, device, biologics, cell & gene therapy).
• Excellent communication skills and a proven track record influencing/building/promoting a culture of Quality and Excellence.
• Strong leadership and an innate ability to mentor, collaborate, and build relationships
• Direct experience with the GMP release of pharmaceutical products, with a preference for experience in Cell & Gene Therapy and/or Biologics products.
• Comprehensive Quality Systems Acumen, strong working knowledge and hands-on experience in key quality processes, including Product Complaints, Recalls, Inspection Readiness, and Event/Quality Issue Management.
• Highly adaptable and flexible, with the ability to thrive in a fast-paced environment and consistently act with urgency.
• Strong oral and written communication and interpersonal skills
• Experienced Lead Auditor
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)
• Experience in GVP, GCP & GLP is desirable.
  
  

Education And Experience

• Bachelor's degree in a biotech/Life sciences field and relevant GDP & GMP work experience.
• Typically requires 6+ years of relevant industry experience in quality assurance and/or quality control in a biotechnology/regulated pharmaceutical environment.
  

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.