Job Title

IntroductionBrunel 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.ResponsibilitiesAct 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).Requirements7-10 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 OfferWhy 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. Well get you going while you get on with the job.About UsBrunel has a reputation for working with some of the best in the business. Thats what we continually strive for. Over 45 years, weve created a global network of interesting clients and talented individuals working together through a vast array of services.