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Manager/Sr. Manager, Validation - CSV & Data Integrity at Genezen - ApplyBlast

Manager/Sr. Manager, Validation - CSV & Data Integrity

Genezen

1 month ago

3.5 on Glassdoor

Lexington, Massachusetts, United States

Onsite

Full Time

Manager

0 applicants

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About this role

The Manager/Sr. Manager, Validation - CSV & Data Integrity leads the strategy, governance, and execution of computer systems validation and data integrity programs for GxP operations, ensuring systems are assessed, validated, and maintained throughout their lifecycle. The role collaborates with cross‑functional teams, provides leadership and mentorship, and supports regulatory compliance and operational excellence.

Responsibilities

Manage computer systems validation strategy and governance
Lead data integrity program and ensure ALCOA+ compliance
Oversee multiple validation projects and cross‑functional teams

Skills

Qualifications

Bachelor’s degree in Engineering, Computer Science or related discipline

About Genezen

genezen.com

Headquarters

Lexington, Massachusetts, United States

Company Size

51-200 employees

Founded

2014

View Profile

Genezen 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.