Data Integrity & QC Systems Lead

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

Benefits offered by this job

Paid vacation days

401(k) with company match

Choice of healthcare plans

Paid sick time

Job summary

Genezen in Lexington, Massachusetts is seeking a Lead, Quality Control Technical Services (QCTS) to ensure data integrity and regulatory compliance for laboratory systems. This role requires strong expertise in 21 CFR Part 11 and GMP environments, along with 10+ years in IT systems validation and management.

The successful candidate will lead the implementation of QC systems, support audits, and contribute to procedural documentation. The position also offers comprehensive benefits, including 401(k) participation and multiple healthcare plans.

Qualifications

• 10+ years of experience in IT Systems/CSV and data integrity.
• Prior experience working in a CDMO environment.
• Subject matter expert in Good Documentation Practices (GDP).

Responsibilities

• Ensure QC laboratory systems comply with 21 CFR Part 11.
• Support audits and inspections as the Data Integrity SME.
• Lead authoring of QCTS procedures and validation protocols.

Skills

21 CFR Part 11 expertise

GMP experience

Computer systems validation

Data integrity practices

Project management

Excellent communication

Education

Degree in science-related field

Tools

MS Word

Excel

MS Project

SmartSheets

Job description

Genezen in Lexington, Massachusetts is seeking a Lead, Quality Control Technical Services (QCTS) to ensure data integrity and regulatory compliance for laboratory systems. This role requires strong expertise in 21 CFR Part 11 and GMP environments, along with 10+ years in IT systems validation and management.

The successful candidate will lead the implementation of QC systems, support audits, and contribute to procedural documentation. The position also offers comprehensive benefits, including 401(k) participation and multiple healthcare plans.