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Associate Director Quality Assurance
4 months ago
Associate Director – Quality Assurance & Regulatory Affairs
Location: Toronto, Ontario
Summary: Join a pivotal leadership role at a top-tier pharmaceutical company focused on pathbreaking scientific advancements. As an Associate Director of Quality Assurance & Regulatory Affairs, you will ensure compliance with Health Canada's stringent standards, maintaining the highest quality in the release of pharmaceutical products. This position promises impactful work in shaping regulatory strategies and enhancing quality systems, crucial for our ambitious Canada market entry.
Why You Should Apply
- Be a part of a global life-sciences company known for scientific innovation and technological breakthroughs.
- Lead strategic regulatory submissions and compliance activities for a new product lineup in Canada.
- Play a key role in establishing and maintaining a robust Quality Management System (QMS).
- Collaborate directly with Health Canada, influencing and responding to regulatory changes.
- Competitive salary and comprehensive benefits package.
- Develop and implement regulatory and quality systems compliant with GMP.
- Oversee regulatory document preparation and submission, including ANDAs.
- Manage Drug Establishment License processes and quality assurance for warehousing and distribution.
- Serve as the main contact for Health Canada, ensuring smooth regulatory interactions and compliance.
- Lead the team through internal and external audits, maintaining continuous system improvement.
- Possess a Bachelor’s or advanced degree in a relevant scientific discipline.
- Have substantial experience in regulatory affairs and quality assurance within the generics pharmaceutical landscape.
- Bring proven expertise in managing Canadian regulatory submissions and quality systems.
- Ability to communicate effectively in multiple settings and forge strong relationships.
We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to and tell me why you’re interested. Or, feel free to email your resume. Please include Job #18677.
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