Senior QA CSV Leader – GxP Systems Validation

Initial Therapeutics, Inc.; United States; Remote; USD 126,000 - 145,000; Full time

Job summary

4DMT is seeking a Sr. QA Computer System Validation Manager to lead validation and lifecycle management of GxP computer systems across GCP, GMP and GLP environments.

You will ensure regulatory compliance (FDA, 21 CFR Part 11; EU Annex 11; GAMP 5) and partner with IT and vendors to maintain validated systems throughout their lifecycle. The role requires 5–7 years in biopharma QA/CSV and strong data integrity expertise, with responsibilities spanning planning, oversight, and inspection readiness.

Qualifications

• Bachelor’s degree required in life sciences, computer science, business or related field.
• 5–7 years in biopharma with QA/CSV experience in both large and small companies.
• 4+ years of QA CSV experience across clinical, quality, lab, or manufacturing systems.
• Strong knowledge of FDA, EMA, MHRA regulatory requirements and data integrity.
• Experience with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 concepts.

Responsibilities

• Provide QA oversight to support CSV activities across full lifecycle of GxP systems.
• Review and approve CSV deliverables and change controls to ensure regulatory compliance.
• Guide day-to-day QA for validation activities and controlled change initiatives.
• Serve as SME in CSV requirements, data integrity and regulatory standards.
• Assist in developing QA/CSV procedures and templates.
• Support audits and inspections and collaborate to drive improvements.
• Partner with IT and external vendors to ensure validated systems remain compliant.

Skills

QA CSV

GxP validation

Regulatory compliance

FDA 21 CFR Part 11

ICH guidelines

Risk-based approach

Vendor management

Audit readiness

Documentation & records

Cross-functional collaboration

Education

Bachelor’s degree in life sciences, computer science, business or related field

Job description

4DMT is seeking a Sr. QA Computer System Validation Manager to lead validation and lifecycle management of GxP computer systems across GCP, GMP and GLP environments.

You will ensure regulatory compliance (FDA, 21 CFR Part 11; EU Annex 11; GAMP 5) and partner with IT and vendors to maintain validated systems throughout their lifecycle. The role requires 5–7 years in biopharma QA/CSV and strong data integrity expertise, with responsibilities spanning planning, oversight, and inspection readiness.