Role Overview

Key Responsibilities

• Act as the primary Quality representative for technology transfer, process validation, and pre-commercialization projects.
• Partner with internal teams and external stakeholders to support project goals and successful execution.
• Review and approve protocols, reports, validation packages, and manufacturing documentation related to technology transfers.
• Collaborate with Research & Development, Regulatory Affairs, Manufacturing Technology, Supply Chain, Quality Control, and external manufacturing partners.
• Participate in contract manufacturing organization qualification activities and associated risk assessments.
• Review and approve quality documentation related to development, validation, and technology transfer activities.
• Establish, maintain, and support the implementation of Quality Agreements.
• Assess GMP compliance of external partners and support audit activities as required.
• Identify, communicate, and help mitigate quality risks affecting projects.
• Review deviations, investigations, Out-of-Specification (OOS) results, Out-of-Trend (OOT) results, CAPAs, and change controls.
• Support regulatory submissions, pre-approval inspections, and commercial launch activities.
• Monitor quality performance metrics and escalate risks that could impact timelines or compliance.
• Participate in continuous improvement initiatives related to technology transfer and product lifecycle management.
• Perform other related duties as assigned.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, or a related scientific discipline.
• Minimum of five (5) years of experience in pharmaceutical development, technology transfer, process validation, or contract manufacturing.
• Knowledge of Good Manufacturing Practice (GMP) requirements applicable in Canada, the United States, and Europe.
• Strong knowledge of GxP regulations applicable in Canada, the United States, and Europe, as well as USP, Ph. Eur., FDA 21 CFR Part 820, ISO 13485, and EU MDR requirements.
• Excellent understanding of pharmaceutical development, process validation, technology transfer, and commercialization activities.
• Knowledge of quality systems, including CAPA, change control, deviations, investigations, and risk management.
• Experience with Quality Agreements and supplier qualification.
• Strong technical writing and document review skills.
• Proficiency with Microsoft Office, SAP, and electronic Quality Management Systems (eQMS).
• Bilingualism in French and English is required. Excellent English communication skills are essential to effectively communicate and collaborate with suppliers, contract manufacturing partners, regulatory agencies, and other key stakeholders located outside Quebec.
• Strong communication, organization, and project management skills.
• Ability to manage multiple priorities with independence and attention to detail.