Senior Specialist, Quality Assurance Operations - Remote

Overview

enGene is seeking a self-motivated and versatile individual to join us as Senior Specialist QA Operations, focusing on quality oversight of external manufacturing partners and ensuring compliance with applicable regulations.

In Short

• Conduct final disposition of clinical and commercial drug products.
• Manage Quality oversight processes for GMP partner sites.
• Support GMP inspections and audits.
• Develop and maintain procedures for GMP operations.
• Compile quality performance metrics.
• Provide operational support for key quality systems.
• Trend metrics related to non-conformances and training compliance.
• Represent Quality input at internal meetings.

Requirements

• Bachelor’s or Master’s degree in a scientific discipline.
• A minimum of 5 years of related QA experience.
• Strong understanding of GMP disposition processes.
• Experience with biologics and/or gene therapies is preferred.
• Experience working with CDMOs preferred.
• Expert knowledge of FDA and ICH regulatory guidance.
• Proficiency in MS Office Suite.
• Effective team working skills.
• Skilled in influencing decisions in a matrixed organization.

Benefits

• Remote work flexibility with some travel required.
• Opportunity to work in a cutting-edge biotechnology environment.
• Engagement in the development of gene therapies.