Senior QA CSV Lead – GxP Systems & Compliance

Openkrill; United States; Remote; USD 126,000 - 145,000; Full time

Job summary

Openkrill is seeking a Sr. QA Computer System Validation Manager to oversee validation, compliance, and lifecycle management of GxP computer systems across GxP environments.

You will partner with business and IT vendors to ensure validated systems stay compliant and provide quality oversight of CSV activities. The role requires expertise in FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ICH guidelines, with a focus on clinical systems and risk-based validation strategies.

Qualifications

• Minimum 5–7 years in biopharma or related industry.
• 4+ years in QA CSV.
• Experience validating clinical trial systems.
• Familiarity with FDA, EU Annex 11, GAMP 5.

Responsibilities

• Provide QA oversight to support business and CSV activities throughout the lifecycle of GxP computer systems.
• Provide Quality oversight of GxP computerized systems not directly managed by 4DMT, including systems operated, hosted, or maintained by external partners or vendors, and review and approve CSV deliverables in adherence to applicable vendor or external partner procedures.
• Review and approve CSV deliverables, IT change management requests, and quality records to ensure adherence to internal procedures and regulatory requirements.
• Review plans and provide day-to-day QA guidance and support to initial validation and steady state activities and controlled change-related initiatives of GxP systems with focus on clinical systems.
• Serve as SME in CSV requirements, data integrity controls and regulatory requirements including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable ICH guidelines.
• Assist in development and refined QA and CSV-related procedures and templates.

Skills

Regulatory understanding

Cross-functional collaboration

Quality oversight

Risk-based validation

Education

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

Tools

GxP systems

CSV deliverables review

Job description

Openkrill is seeking a Sr. QA Computer System Validation Manager to oversee validation, compliance, and lifecycle management of GxP computer systems across GxP environments.

You will partner with business and IT vendors to ensure validated systems stay compliant and provide quality oversight of CSV activities. The role requires expertise in FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ICH guidelines, with a focus on clinical systems and risk-based validation strategies.