Quality Assurance Manager-Imports

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Those who join Emergent Bio Solutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Quality Assurance (QA) Manager is responsible for ensuring that all imported pharmaceuticals and medical devices comply with Canadian regulatory requirements, including those set by Health Canada. This role supports the development, implementation, and maintenance of the Quality Management System (QMS) and ensures adherence to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Medical Device Regulations (SOR/98-282).

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Ensure compliance with Health Canada regulations for pharmaceuticals (C.01,
  
  C.02) and medical devices (SOR/98-282).
• Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485, GMP, and GDP standards.
• Review and approve product release documentation, Certificates of Analysis (CoAs), and shipping records.
• Support internal audits and external inspections by regulatory authorities (e.g., Health Canada, FDA).
• Manage deviation reports, CAPAs, and change controls to ensure timely resolution and continuous improvement.
• Oversee complaint handling, product recalls, and post‑market surveillance activities.
• Collaborate with Regulatory Affairs to ensure timely product registrations, license renewals, and regulatory submissions.
• Train staff on quality procedures, regulatory updates, and best practices in compliance.
• Maintain document control and ensure SOPs are current, compliant, and effectively implemented.
• Coordinate with internal logistics to ensure proper storage, handling, and transportation of products.
• Monitor environmental conditions and storage requirements for temperature‑sensitive products.
• Support validation and qualification activities (e.g., equipment, processes, cleaning, software).
• Participate in supplier qualification and audits to ensure compliance with quality standards.
• Analyze quality data and trends to identify risks and opportunities for improvement.
• Prepare and present quality metrics and reports to senior management.
• Ensure proper handling and documentation of returned goods and non‑conforming products.
• Stay current with evolving regulatory requirements and industry best practices.
• Lead risk‑management activities, including FMEA and risk assessments.
• Drive quality improvement initiatives and cross‑functional collaboration to support business goals.

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering or a related field.
• 10 years of QA experience in pharmaceuticals and/or medical devices.
• Minimum 5 years of progressive management experience in Quality Assurance or Regulatory Affairs.
• Experience in the importation of products into the Canadian market.
• Strong knowledge of Canadian regulatory requirements (Health Canada, GMP, GDP, ISO 13485).
• Proven experience managing quality systems, audits, and CAPA programs.
• Excellent leadership, attention to detail, organizational, and communication skills.
• Ability to take complex information and make quality decisions in accordance with quality policies.
• Proficiency in Microsoft Office and QMS software.
• Bilingual (English/French) is considered an asset.
• Experience with importation processes and third‑party logistics (3PL) is considered an asset.
• Familiarity with FDA and EU regulatory frameworks is considered an asset.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

As part of our team, you’ll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work…