Sr. QA Computer System Validation Mgr.

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

For our client, we are seeking a Sr. QA Computer System Validation Mgr. to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will provide quality oversight for GxP computer systems across their full lifecycle, with a strong focus on clinical trial systems and data integrity. You will partner closely with internal stakeholders, external vendors, and audit teams to ensure validation activities and quality records support regulatory expectations. The position also offers the opportunity to shape procedures, templates, and inspection readiness efforts in a highly regulated environment.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $126,000 – $145,000 annually

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.

Qualifications

• Bachelor's degree in life sciences, computer science, business, or a 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.

Benefits

• Collaborative work environment with cross-functional teams.
• Opportunities for professional development and training.
• Support for inspection readiness initiatives and audits.
• Engagement with external partners and vendors for diverse experience.

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.