Introduction:
We are seeking a detail-oriented and proactive Commercial Quality Specialist to join our client’s team, a global leader in the pharmaceutical industry committed to upholding the highest standards of product quality and regulatory compliance. Based out of the Saint-Laurent, Montreal Head Office , this position offers a hybrid work model (three days in-office, with Tuesday and Wednesday mandatory ) and is a contract opportunity through April 30, 2026 . Working four days per week (29 hours weekly) , this role is ideal for a professional with a strong understanding of Good Manufacturing Practices (GMP) who thrives in both independent and collaborative environments.
As the Commercial Quality Specialist, you will independently support Commercial Quality operations across the affiliate, ensuring compliance with quality system requirements related to pharmaceutical products, biologics, medical devices, combination products, and cosmetics. You will play a key role in maintaining and enhancing quality systems, supporting audits and inspections, managing quality events, and ensuring adherence to corporate and regulatory standards.
Responsibilities:
- Integrate and apply local quality regulations for drugs, biologics, devices, combination products, and cosmetics.
- Design and implement effective quality systems, procedures, and processes within cross-functional teams to ensure compliance and operational efficiency.
- Perform assessments to determine compliance with procedures and regulations; identify potential gaps and support the development and execution of improvement plans.
- Plan, prepare, review, and approve quality documentation such as change controls, product quality reviews, and other local requirements.
- Support self-inspections, internal audits, external audits, and Ministry of Health inspections as directed by management.
- Coordinate and investigate quality events such as deviations and non-conformances, and manage corresponding action plans and decisions.
- Execute supplier qualification programs and monitor performance for key suppliers.
- Monitor key quality metrics and KPIs to ensure ongoing compliance and effectiveness.
- Support activities governed by Good Storage and Distribution Practices, including controlled temperature and cold chain monitoring.
- Support the Management Review process at the affiliate level.
- Represent Commercial Quality in cross-functional projects and initiatives as assigned by management.
Requirements:
- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other relevant scientific or technical field (required).
- 2+ years of experience in Quality Assurance within a GMP or GDP environment (preferred).
- Comprehensive understanding of local GxP requirements, including applicable regulations and standards for pharmaceuticals, biologics, devices, and cosmetics.
- Strong computer skills, with proficiency in SAP, TrackWise, ComplianceWire, and OneVault.
- Ability to work effectively both independently and collaboratively within cross-functional teams.
- Demonstrated ability to learn quickly, manage multiple priorities, and make sound decisions in partnership with management.
- Excellent organizational, analytical, and communication skills with high attention to detail.
- Experience supporting or participating in audits, inspections, or other quality compliance activities is an asset.
What We Offer
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About Us
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