Associate Manager Quality Assurance

Step into a vital role at Regeneron as an Associate Manager of Quality Assurance in Toronto, Canada. This hybrid position focuses on overseeing biologic product quality in accordance with Health Canada standards.

As an Associate Manager, you will provide quality oversight of batch dispositions for both commercial and clinical biologic products. This role requires at least 5 years of Quality Assurance experience in GMP-regulated environments, where you will manage quality documentation and ensure compliance during audits. Your expertise will support the importation and distribution of biologics in Canada while collaborating with cross-functional teams to enhance quality initiatives.

Key Responsibilities:

• Act as Deputy Responsible Person for batch compilation and release

• Oversee quality metrics and manage compliance issues

• Create and approve quality documentation including SOPs and CAPAs

• Support Health Canada inspections and audits as a quality SME

• Collaborate with global Quality teams for continuous improvement

Requirements:

• Bachelor’s degree in Life Sciences or equivalent

• Minimum 5 years of experience in Quality Assurance

• Knowledge of GMP and GDP regulations

• Strong problem-solving and communication skills

• Experience with biologics importation and 3PL management

Enhance your career in quality assurance and contribute to life-changing medicines at Regeneron.
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