Senior Specialist, Quality Assurance Operations
enGene
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • United States
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Salary
💰 $115,000 - $135,000 per year
Job Level
About the role
- 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.
Requirements
- 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
- Experience with biologics and/or gene therapies is preferred
- Experience working with CDMO or experience working at a biologics CDMO preferred
- This role will be required to travel approximately 15-20% travel to support CDMO production and inspection activities.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMPquality oversightCAPAchange controlrisk managementdocument managementtraining compliancebatch record reviewfinal dispositionquality performance metrics
Soft skills
communicationproblem-solvingcollaborationorganizational skillsleadership
Certifications
Bachelor's degreeMaster’s degree