enGene · 6 days ago
Senior Specialist, Quality Assurance Operations
Boston, MA
Full-time
Onsite
Mid, Senior Level
$115K/yr - $135K/yr
7+ years expenGene is a late-stage biotechnology company focused on genetic medicines. The Senior Specialist QA Operations will oversee quality assurance activities with external manufacturing partners, ensuring compliance with regulations and supporting GMP operations.
BiotechnologyDiabetesGeneticsHealth Care
Responsibilities
Perform batch record review and facility issue resolution with GMP partner sites (CDMO)
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
Support the development and maintenance of procedures and quality systems for GMP operations
Support compilation of quality performance and compliance metrices 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
Qualification
Required
Bachelor's or Master's degree in a scientific discipline
A minimum of 7 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
Expert knowledge of FDA and ICH regulatory guidance and regulation specific to GMP product manufacturing 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 clinical trials
Proficiency in MS Office suite
Effective team working skills with cross-functional teams
Skilled in influencing and escalating within a matrixed organization to drive decisions
This role will be required to travel approximately 15-20% travel to support CDMO production and inspection activities
Preferred
Experience with biologics and/or gene therapies is preferred
Experience working with CDMO or experience working at a biologics CDMO preferred
Company
enGene
enGene is a biotechnology company develops treatment for mucosal diseases through inducing therapeutic proteins of harmful proteins.
11-50 employees
H1B Sponsorship
enGene has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
Funding
Current Stage
Public CompanyTotal Funding
$391.75MKey Investors
Hercules CapitalCystic Fibrosis FoundationForbion Capital Partners
2025-11-13Post Ipo Equity· $92.81M
2024-10-25Post Ipo Equity· $43.19M
2024-02-14Post Ipo Equity· $200M
Leadership Team
Ron Cooper
Chief Executive Officer | Member, Board of Directors
Joan Connolly
Chief Technology Officer
Recent News
2025-12-24
Company data provided by crunchbase