Lead CSV & Data Integrity Manager (GxP)

Genezen; Lexington (MA); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match up to 6

Healthcare plans

FSA and HSA programs

Job summary

Genezen in Lexington, MA is seeking a Manager/Sr. Manager, Validation - CSV & Data Integrity to lead the CSV program for GxP systems across lab and manufacturing operations.

You will define validation strategies, oversee IQ/OQ/PQ, and drive data integrity practices in collaboration with QA, IT and process owners. The role requires 10+ years of CSV experience, a Bachelor’s degree in Engineering or related field, and deep knowledge of ALCOA+ data lifecycle, regulatory expectations and GAMP 5.

Qualifications

• Bachelor’s degree in Engineering, ComputerScience or related discipline.
• 10+ years of Computer System Validation experience.
• Strong understanding of CSV, GxP regulations and data lifecycle management.
• Experience with IQ/OQ/PQ, risk assessments and validation documentation.
• Collaboration across QA, IT, manufacturing and QA/QC.

Responsibilities

• Lead the CSV strategy, governance and risk-based validation for GxP systems.
• Develop standards, templates and procedures for validation activities.
• Oversee validation deliverables: URS, IQ/OQ/PQ, protocols and traceability.
• Ensure systems remain validated and compliant throughout their lifecycle.
• Provide CSV leadership during audits and regulatory inspections.

Skills

CSV leadership

Data integrity

GxP knowledge

Regulatory alignment

Cross-functional collaboration

Project management

Education

Bachelor’s degree in Engineering

ComputerScience or related

Job description

Genezen in Lexington, MA is seeking a Manager/Sr. Manager, Validation - CSV & Data Integrity to lead the CSV program for GxP systems across lab and manufacturing operations.

You will define validation strategies, oversee IQ/OQ/PQ, and drive data integrity practices in collaboration with QA, IT and process owners. The role requires 10+ years of CSV experience, a Bachelor’s degree in Engineering or related field, and deep knowledge of ALCOA+ data lifecycle, regulatory expectations and GAMP 5.