QC Data Integrity & Computerized Systems Lead

Genezenlabs; Lexington (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Paid vacation days based on tenure

401(k) plan with company match

Choice of several healthcare plans

Job summary

Genezenlabs is looking for a Lead, Quality Control Technical Services (QCTS) – Data Integrity responsible for oversight of QC laboratory systems and compliance with regulatory standards. This role provides expertise across system implementation and data governance activities.

The ideal candidate will have significant experience in IT Systems, possess a science-related degree, and is committed to maintaining high data integrity standards within a GMP environment.

Qualifications

• 10+ years of experience in IT Systems/CSV, Enterprise Solutions, QMS, and data integrity.
• Good Manufacturing Practices (GMP) experience required.
• Experience in Excel spreadsheet validation.

Responsibilities

• Ensure QC laboratory systems comply with 21 CFR part 11.
• Lead lifecycle management activities for QC systems.
• Support QC investigations involving data integrity.

Skills

Subject matter expert in 21 CFR Part 11

Excellent computer literacy (MS Word, Excel)

Excellent executive communication skills

Prior experience working in a CDMO environment

Education

Degree in science-related field

Tools

Veeva (Enterprise Solutions)

MS Project

Job description

Genezenlabs is looking for a Lead, Quality Control Technical Services (QCTS) – Data Integrity responsible for oversight of QC laboratory systems and compliance with regulatory standards. This role provides expertise across system implementation and data governance activities.

The ideal candidate will have significant experience in IT Systems, possess a science-related degree, and is committed to maintaining high data integrity standards within a GMP environment.