Remote CSV Lead — Clinical Systems QA & Data Integrity

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

Benefits offered by this job

Remote work (US)

Professional development

Audit readiness support

Vendor engagement

Job summary

Ladders is seeking a Sr. QA Computer System Validation Manager to oversee GxP computer systems across their lifecycle, with emphasis on clinical trial systems and data integrity.

The role partners with internal teams, vendors, and auditors to ensure validation activities meet regulatory expectations and quality records support inspections. Remote within the US; visa sponsorship not available.

Qualifications

• Bachelor's degree in life sciences, computer science, business or related field.
• 5-7 years of experience in the biopharmaceutical industry, ideally in both large and small companies.
• 4+ years of experience in QA Computer System Validation (CSV).
• Strong background in clinical trial computer systems across all development phases.
• Expertise in regulatory compliance (FDA, EMEA, MHRA) and ICH guidelines.

Responsibilities

• Provide QA oversight for GxP computer systems throughout their lifecycle.
• Review and approve CSV deliverables from external partners and vendors.
• Ensure compliance with internal procedures and regulatory standards through quality record reviews.
• Guide initial validation and ongoing activities for clinical systems.
• Act as a subject matter expert on CSV requirements and data integrity controls.
• Assist in developing QA and CSV-related procedures and templates.
• Support audits and inspections for IT vendor qualification.

Skills

GxP CSV

Data integrity

Regulatory compliance

Clinical systems

Education

Bachelor's degree in life sciences, computer science, business

Job description

Ladders is seeking a Sr. QA Computer System Validation Manager to oversee GxP computer systems across their lifecycle, with emphasis on clinical trial systems and data integrity.

The role partners with internal teams, vendors, and auditors to ensure validation activities meet regulatory expectations and quality records support inspections. Remote within the US; visa sponsorship not available.