Senior CSV Manager – GxP Systems Quality & Compliance

4DMT; United States; On-site; USD 126,000 - 145,000; Full time

Job summary

4DMT is seeking a Sr. QA Computer System Validation Manager to oversee validation, compliance, and lifecycle management of GxP computer systems across FDA/EMA-compliant environments.

You will partner with IT and business teams to ensure validated systems remain compliant throughout their lifecycle, providing QA oversight of CSV activities for clinical, manufacturing, and enterprise systems. The role requires strong expertise in regulatory standards (FDA 21 CFR Part 11, EU Annex 11, GAMP 5) and

Qualifications

• Bachelor’s degree in life sciences, computer science, business or related field.
• 5–7 years in biopharmaceutical industry; preferable in both large and small company environments
• 4+ years experience in QA CSV
• Strong experience supporting computer systems used in clinical trials through all phases of development
• Extensive experience supporting the validation of clinical systems (e.g. IRT, EDC. eTMF)
• Thorough working knowledge of computer systems validation and computer software assurance
• Experience with enterprise, quality, lab and clinical systems ensuring compliance with FDA, EMEA, MHRA and other regulatory requirements
• Expertise in ICH guidelines, 21CFR Part11 and EU Annex 11 regulations, data integrity and GAMP 5 concepts, application and best practice
• Experience supporting regulatory inspections and audits
• Demonstrated ability to apply risk-based approaches to information system selection, testing, implementation and maintenance.

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 (e.g. NCRs, CAPAs) to ensure adherence to 4DMT’s internal procedures and policies, and applicable regulatory requirements and standards.
• 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 subject matter expert (SME) in CSV requirements, data integrity controls and related regulatory requirements / standards including FDA 21 CFR Part11, EU Annex 11, GAMP 5, and applicable ICH guidelines
• Assist in development and/ or refined QA and CSV-related procedures and templates
• Support audits for qualification and requalification of IT vendors
• Collaborate across functions and within Quality to identify areas of improvements and implement enhancements
• Support inspection readiness initiatives, audits and regulatory inspections
• Other duties as assigned or reassigned as needed by management

Skills

Quality assurance

CSV

Regulatory compliance

GxP systems

Cross-functional teamwork

Vendor management

Documentation

Audit readiness

Risk-based approach

Education

Bachelor’s degree

Tools

IRT

EDC

eTMF

GxP systems

Job description

4DMT is seeking a Sr. QA Computer System Validation Manager to oversee validation, compliance, and lifecycle management of GxP computer systems across FDA/EMA-compliant environments.

You will partner with IT and business teams to ensure validated systems remain compliant throughout their lifecycle, providing QA oversight of CSV activities for clinical, manufacturing, and enterprise systems. The role requires strong expertise in regulatory standards (FDA 21 CFR Part 11, EU Annex 11, GAMP 5) and