Medicago Hiring for Manager Quality Assurance at Quebec City, QC Full Time

We started our journey with one objective: to help protect human life and today, we are a global leader in developing and producing plant-based vaccines and therapeutics.

Your role:
The incumbent oversees development, maintenance and improvement of quality systems and processes to ensure compliance with laws, regulations and quality standards in relation to Medicago’s preclinical, clinical and pharmacovigilance activities. Through supervision of her/his team, she/he ensures development, coordination, and maintenance of the various processes, governances, and committees related to quality systems, suppliers, and inspection support/readiness.

What your days would look like:

• Oversee Department’s Quality Systems inclusive of ownership of QA records, authorship of procedures; development and oversight of monitoring activities (metrics, trending), coordination of activities related to document management and document control.
• Coordinate clinical inspection readiness program inclusive of preparation and performance of internal audits and follow up on outcomes and resulting corrective actions; develop assessments of QA team inspection readiness and resulting actions.
• Coordinate QA team preparations, requests, and deliverables for Regulatory inspections as well as tracking resulting Health Authority commitments; lead discussions with Health Authorities.
• Lead Compliance Projects or represent QA in projects where Clinical and PV QA input and support is required, including associated QA deliverables.
• Coordinate improvements to the compliance and efficiency of Clinical and PV QA systems, processes, and procedures. Contribute significantly to long term strategy development.
• Supervise the quality oversight of Medicago’s suppliers, inclusive of: development of supplier/CRO quality framework, audits and follow up on outcomes and resulting corrective actions; quality agreements; assessments of services and supplier criticality and risk; maintaining and tracking documentation and status of activities required to ensure compliance.
• Manage resolution of compliance and quality issues identified at vendors used by clinical and pharmacovigilance operations and assess impact of the deficiencies as needed. Escalate critical issues to management.
• Ensure compliance to regulatory standards for the operation and data generation of clinical sample testing by the serology laboratory and provide compliance guidance and advice.

Required profile:

• Bachelor’s degree in Science or Engineering;
• 10+ years of related quality or clinical/pharmacovigilance experience including 2-3 years as a manager or supervisor exhibiting strong change management and planning and organizational skills
• Demonstrated people management skills
• Experience with enterprise applications (example: Veeva Vault, 365 Dynamics, MasterControl); Experience with ARGUS safety database a plus
• Experience in establishing and managing quality systems for GCP and PV in compliance with the regulatory expectations (FDA, Health Canada, EMA)
• Strong interpersonal, written, oral communication skills and presentation skills
• Demonstrates initiative and proactively provides collaborative support to teams.

Medicago is changing the game!

Our Vision: Medicago envisions a world that is prepared to face any disease

Our Mission: To create and deliver effective responses to new global health challenges.

Our mission is driven by the values of innovation, integrity, collaboration, adaptability, and ownership. These values reflect the spirit and culture that inspire Medicago’s people.

As a pioneer in transient expression and plant-based manufacturing, Medicago has always sought a more effective way to improve human health. With nearly 20 years of experience and wisdom behind us, we are poised to revolutionize the traditional approach to vaccines and therapeutics.

It is important that you are legally entitled to work in the US or Canada at the time the job offer is made to you. You may be asked to provide proof of eligibility.

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