Associate Manager - Quality Assurance (Biologics)

Location: Toronto, Canada (hybrid)

Company

hirify.global is a biotechnology company developing and commercializing medicines for serious diseases.

What you will do

• Act as Deputy Responsible Person for batch compilation, review, disposition, and release of Canadian-market biologic products.
• Provide GMP quality oversight for commercial and clinical products and monitor timely batch disposition.
• Create, revise, and approve Change Controls, Deviations, CAPAs, Complaints, SOPs, and APQRs.
• Monitor quality system metrics and resolve complex quality and compliance issues using risk-based judgment.
• Oversee Canadian importation and distribution activities, including third-party logistics providers.
• Support Health Canada inspections, audits, self-inspections, recalls, and continuous improvement with local and global Quality teams.

Requirements

• Canadian Bachelor's degree in Life Sciences, such as Biology, Chemistry, Pharmacy, or an equivalent field.
• At least five years of Quality Assurance experience in pharmaceutical, biotechnology, or biologics environments.
• Demonstrated experience in GMP-regulated environments, including batch record review, batch release, deviations, change controls, CAPAs, and quality systems management.
• Strong understanding of Health Canada GMP and GDP requirements, with experience supporting regulatory inspections and audits.
• Excellent written, verbal, organisational, and problem-solving skills, with the ability to work independently and across global teams.

Nice to have

• Experience overseeing biologics importation and distribution in Canada.
• Experience overseeing third-party manufacturers or 3PL providers.
• Experience with medical device importation in Canada or within a global Quality organisation.

Culture & Benefits

• Hybrid work mode for the Toronto-based role.
• Inclusive culture and equal employment opportunity.
• Competitive total rewards may include bonuses, equity awards, pension or retirement benefits, insurance, paid time off, and family support benefits.
• Reasonable accommodation is available during recruitment where required.