Senior Specialist, Quality Assurance Operations

enGene (NASDAQ: ENGN) is a late-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead program EG-70 is being evaluated in an ongoing pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG). EG-70 was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. For more information, visit enGene.com.

Role

enGene is seeking a self-motivated and versatile individual to join us as Senior Specialist QA Operations within the Quality organization. This is a key role focused on Quality oversight of enGene’s external manufacturing partners (CDMOs), including management and oversight of product disposition activities and quality events.The candidate will work closely with enGene’s CMC Operations, Quality Control, and Regulatory team members. This role is critical in maintaining a strong partnership with enGene’s CDMOs in pursuit of advancing our pipeline and is expected to be hands-on in the technical and operational details of the Quality Assurance operations at external manufacturing sites, with focus on product disposition and Quality systems/event management. 

• Conduct final disposition of clinical and commercial drug product, ensuring that disposition is conducted in compliance with applicable regulations and requirements. Includes coordination with QPs as required.
• Manage processes for demonstrated Quality oversight of GMP partner sites, including partner investigations, CAPA, and change controls. Identify and communicate quality and compliance risks to senior Quality management and participate in determination of appropriate plan to address such risks.
• Support GMP inspections and audits at Company’s GMP partner sites (CDMOs)
• Support the development and maintenance of procedures and quality systems for GMP operations.
• Support compilation of quality performance and compliance metrics as relates to product disposition and GMP partner site operations
• Responsible for providing operational support for key quality systems (e.g. risk management, complaints, document management, training and change control).
• Trend metrics related to non-conformances/CAPAs, training compliance at partner sites along with product disposition metrics.
• Represent Quality input at internal cross functional and CDMO meetings.

• Expert knowledge of FDA and ICH regulatory guidance and regulation specific to GMP product manufacture and disposition
• Thorough knowledge of current Good Manufacturing Practices and deep understanding of aseptic processing guidelines as they relate to the production of gene therapy products for human clinical trials.
• Proficiency in MS Office Suite including MS Project.
• Effective team working skills with cross-functional teams.
• Skilled in influencing and escalating within a matrixed organization to drive decisions

• Bachelor’s or Master’s degree in a scientific discipline
• A minimum of 5 years of related QA experience in pharmaceuticals or biologics. Experience with multi-region (US, EU, ROW) commercial Quality preferred.
• Strong understanding of GMP disposition processes for clinical and commercial drug substance and drug product for US and ROW
• Experience with biologics and/or gene therapies is preferred
• Experience working with CDMOs or experience working at a biologics CDMO preferred
• This is a remote role with approximately 15-20% travel to support CDMO production and inspection activities.

enGene USA Inc. is an Equal Opportunity Employer:

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.  At enGene USA Inc., we are building a community of intelligent and passionate team members that share our Vision, Mission, and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.