Introduction
Brunel is partnering with a newly built, government-funded GMP biomanufacturing facility dedicated to producing clinical trial materials for innovative biologics and vaccines across Canada. Our client is looking to hire a Senior QC Consultant (Bilingual En/Fr) to focus on specifications, data review, and strategic QC input to ensure compliance with Canadian GMP, FDA cGMP and EU (Eudralex) expectations.
Responsibilities
- Act as a senior QC subject-matter expert within a multidisciplinary team supporting clinical biologics and vaccine programs.
- Help develop and refine specifications for biological products, including drug substance, drug product, MCB/WCB and intermediates.
- Advise on test strategies and panels to be performed for client projects, aligned with relevant regulatory guidance.
- Review and interpret QC data and environmental monitoring (EM) trending; provide recommendations based on trends and microbiological findings.
- Support or oversee the generation, review and optimization of QC SOPs, work instructions and related documentation.
- Contribute to annual QC reports, data summaries and trending analyses, ensuring regulatory and internal policy compliance.
- Collaborate with the QC lead on weekly progress reviews, deliverables and prioritization of tasks.
- Support other QC activities as needed (specifications, data analysis, document generation/review).
Requirements
- 7-10 years’ experience in a GMP environment for biologics (QC, QA or related technical roles).
- Minimum 5 years’ experience in establishing specifications for biological products (clinical and/or commercial).
- Minimum 5 years’ experience as QA or QC in a biomanufacturing facility for sterile products (e.g., biologics, vaccines).
- Degree in Sciences (minimum B.Sc. or equivalent).
- Strong knowledge of Canadian GMP, FDA cGMP and EU (Eudralex) requirements.
- Demonstrated experience reviewing QC data, identifying trends and translating findings into clear, actionable recommendations.
- Fluent in both French and English (spoken and written).
- Legally eligible to work in Canada.
- Experience supporting new facility start-up, clinical trial material facilities or tech transfer projects.
- Prior consulting experience or working across multiple products/clients.
What We Offer
Why apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. We’ll get you going while you get on with the job.
About Us
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
