Quality Assurance Specialist, Audit and Vendor Qualification

Quality Assurance Specialist, Audit and Vendor Qualification

Aramis Biotechnologies | Quebec City | Full-time

Your mission in one sentence:

Use your expertise in quality assurance, GxP audits, and vendor management to build a strategic vendor qualification program that supports the development of next-generation biotechnological solutions.

In summary, in this role you:

• Develop and implement Aramis' vendor qualification program.
• Conduct vendor qualifications and audits using a risk-based approach.
• Ensure regulatory and documentary compliance of the program according to GMP/BPF and GCP/BPC requirements.

What does your day look like?

• Develop, implement, and evolve the vendor qualification program.
• Identify vendors, assess their criticality, and conduct initial and periodic qualifications.
• Plan, coordinate, and conduct on-site or remote vendor audits.
• Monitor deviations, action plans, and vendor performance.
• Write and maintain associated quality documentation (SOP, templates, processes, and tools).
• Advise internal teams on vendor risks and collaborate with various internal teams.
• Contribute to continuous improvement of the quality system and preparation for regulatory inspections.
• The team you'll join

You join the Quality Assurance team and report to the Quality Assurance Director.

In this cross-functional role, you'll work daily with the Procurement, Operations, and Regulatory Affairs teams. You'll also collaborate with numerous external partners and vendors.

What will help you succeed

Essential:

• Bachelor's degree in life sciences, biotechnology, or related field.
• Experience in quality assurance in a GxP environment.
• Experience in vendor qualification, management, or auditing.
• Experience in a pharmaceutical, biotechnological, or highly regulated environment.
• Strong knowledge of GMP/BPF, GCP/BPC requirements, and regulatory expectations.
• A plus:
• Experience in regulatory inspection of biological products or vaccines.
• Quality auditor certification (ASQ CQA or equivalent).
• What sets you apart:
• Demonstrate rigor, judgment, and an excellent sense of quality risk.
• Build trust-based relationships and exercise influential leadership.
• Enjoy collaborating, taking initiative, and driving progress in a growing environment.
• A little more about us

Aramis Biotechnologies is a Canadian company based in Quebec and recognized as a global leader in plant bioproduction.

Through strategic partnerships, we develop innovative and sustainable bioproduction solutions to meet the evolving needs of industry and society.

This work environment unites all employees in the pursuit of a common goal: building Canadian production capacity and making a difference with next-generation, eco-responsible bioproduction.

What you'll gain by joining us

• The opportunity to become a shareholder and contribute to the development of an innovative, impactful company.
• Recognition of your years of experience on the market for calculating your vacation days.
• Health insurance, life insurance, telemedicine service, and employee assistance program.
• A REER program with company participation.
• Flexible hours and the possibility of hybrid work, depending on the nature of the position.