Quality Assurance Manager

Atrium; Toronto; Hybrid; CAD 100,000 - 125,000; Full time

Job summary

A staffing agency is seeking a Quality Assurance Manager for a contract role in Toronto, Canada. The position involves ensuring compliance with regulatory standards for product distribution and managing quality systems within the organization. Ideal candidates will have over 6 years of experience in quality assurance within biotech or pharma, demonstrating strong communication and leadership skills. Competitive compensation is offered with a hybrid work model.

Qualifications

• 6+ years in quality assurance/control in biotech/pharma environment.
• Experience as Lead Auditor is preferred.
• Knowledge of US, Canadian, and international regulations.

Responsibilities

• Ensure quality frameworks meet regulatory expectations.
• Manage release and batch certification of products.
• Prepare for and support Health Canada inspections.

Skills

GxP Regulations

Excellent communication

Leadership skills

GMP release experience

Quality Systems knowledge

MS Office proficiency

Education

Bachelor's in biotech or Life sciences

Job description

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This range is provided by Atrium. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range: $60.00/hr - $65.00/hr

The Quality Assurance Manager, Vertex Canada, holds primary responsibility for providing comprehensive quality oversight of all product distribution activities within Canada. This role manages GMP release of products, ensuring adherence to Vertex's SOPs, policies, and industry guidance.

This position requires collaboration with internal teams and external Contract Manufacturing Organizations and laboratories to ensure compliance with cGMP / GDP. It is crucial in establishing and maintaining robust quality systems for Canadian operations.

This is a 24-month contract with the possibility of full-time conversion. Hybrid work with 3 days in Toronto office.

Reports to: Associate Director, Market Quality - Regional QA Lead

The responsibilities include, but are not limited to:

1. Ensuring quality frameworks, guidance, and Canadian quality systems meet regulatory expectations and Vertex’s QMS throughout the product lifecycle.
2. Maintaining and updating Canadian quality system documents, SOPs, Quality Agreements, and writing/reviewing Quality Technical Agreements (TQAs).
3. Managing release and batch certification of Vertex Canada products.
4. Supporting maintenance of the Vertex Canada Drug Establishment License.
5. Participating in internal and external audits, including Canadian warehouses and contract organizations.
6. Preparing for and supporting Health Canada inspections, responding to information requests, and managing corrective actions.
7. Evaluating service providers, facilities, personnel, and practices to meet regulatory requirements.
8. Reviewing compliance documentation such as Stability Reports, Process Validation Documents, and Certification records.
9. Collaborating across departments to execute tasks and participate in projects representing Vertex Canada.
10. Identifying risks, resolving issues, managing OOS, and mitigating gaps.
11. Monitoring and reporting quality indicators, leading Quality Management Reviews.
12. Documenting events, CAPA, and changes in line with risk principles.
13. Implementing and maintaining training programs.
14. Performing product recalls and mock recalls annually.
15. Handling customer complaints effectively.
16. Providing global support as SME for various projects.
17. Approving subcontracted activities impacting GDP.
18. Adhering to additional legal requirements for certain products.
19. Ensuring compliance with Pharmacovigilance Agreements.
20. Supporting ad-hoc tasks and projects as needed.

Knowledge and Skills:

• Expertise in GxP Regulations, GMP, GDP, with knowledge of US, Canadian, and international regulations.
• Excellent communication and leadership skills.
• Experience with GMP release of pharmaceutical products, preferably in Cell & Gene Therapy or Biologics.
• Strong understanding of Quality Systems and processes.
• Experience as Lead Auditor.
• Proficiency in MS Office.
• Experience in GVP, GCP, GLP is desirable.

Education and Experience:

• Bachelor's in biotech or Life sciences; relevant GDP & GMP experience.
• 6+ years in quality assurance/control in biotech/pharma environment.

Pay Range: $60/hr - $65/hr

Requisition Disclaimer: This is a temporary role via a third-party agency at Vertex. Compensation and benefits are provided by the agency. Actual pay depends on skills and experience. Overtime may apply.

By applying, you agree to Atrium's Terms and Conditions and authorize sharing your application with Vertex. For data privacy details, see Vertex’s Careers Privacy Notice. You may opt out of Atrium Alerts by contacting [e-mail].

If you do not agree, you can still apply by emailing your resume to [e-mail] with the job title in the subject line.

No C2C or third-party vendors accepted.