Lead, Quality Systems
Genezen
About this role
The Quality Systems Lead administers and enhances Genezen's Quality Management System with emphasis on electronic QMS support, risk assessments, inspection readiness, and regulatory compliance. The role ensures inspection and audit readiness, supports regulatory surveillance, and partners with cross-functional teams to maintain quality standards. This position drives continuous improvement initiatives and governance of quality-related documentation and processes.
Skills
Qualifications
About Genezen
genezen.comGenezen is a contract development and manufacturing organization (CDMO) focused on viral vector production to accelerate gene and cell therapies. It provides expertise, GMP-capable facilities, and end-to-end capabilities to support process development, scale-up and commercial manufacturing for advanced biologics. Genezen positions itself as a partner to biotech and pharma teams, offering quality systems, analytical support, and manufacturing capacity to shorten timelines and reduce development risk.
Recent company news
PR NewswireGenezen and Atsena Therapeutics Announce Strategic Commercial Manufacturing Partnership
1 month ago
PR NewswireGenezen Announces Manufacturing Partnership with Humane Genomics to Advance Oncolytic Virus Therapy for Pediatric Liver Cancer
Nov 12, 2025
Indianapolis Business JournalPharmaceutical company planning to relocate from California to Fishers
Jun 17, 2025
Fierce PharmaUniQure sells gene therapy manufacturing site to Genezen, along with production of CSL's Hemgenix
Jul 1, 2024
Manufacturing DiveUniQure outsources Hemgenix manufacturing operations
Jul 10, 2024
About Genezen
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
Unlock Company Insights
View leadership team, funding history,
and employee contacts for Genezen.
Salary
$129k – $174k
per year
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