Senior GCP Auditor

Ladders; United States; Remote; USD 140,000 - 154,000; Full time

Benefits offered by this job

Medical, dental, and vision plans

EAP

401(k) with company match

Unlimited PTO

529 education savings program

Wellness programs

Job summary

Ladders is seeking a Senior GCP Auditor to reinforce quality systems in a regulated biotech/pharma environment. This role focuses on GCP standards across trial operations, partnering with internal teams and vendors to ensure audit readiness and timely resolution of compliance issues.

The position is remote with US-based candidates only, offering a competitive salary and comprehensive benefits. A detail-oriented professional who can balance documentation rigor with cross-functional problem

Qualifications

• Bachelor's or Master's degree in life sciences or engineering.
• 7+ years of experience in a GCP-biologics or pharmaceutical setting with a Bachelor's degree, or 4+ years with a Master's degree.
• CQA or similar audit certification preferred.
• Experience with TMF or electronic document management systems preferred.
• Strong analytical skills and attention to detail.

Responsibilities

• Maintain and update the clinical trial quality management system.
• Contribute to the development and review of SOPs and controlled documents.
• Ensure compliance with ICH GCP E6 (R2) standards.
• Manage the incident management program, including monitoring complaints and deviations.
• Conduct vendor, supplier, and clinical trial site audits.
• Prepare documentation for audit activities and follow-up resolutions.
• Collaborate across teams to address GCP compliance issues.

Skills

Analytical skills

Attention to detail

Education

Bachelor's or Master's in life sciences or engineering

Tools

TMF system

Electronic document management

Job description

For our client, we are seeking a Senior GCP Auditor to join the team of a leader in the Pharmaceuticals & Biotech space. This role will help ensure clinical quality and compliance across trial operations, with a focus on Good Clinical Practice (GCP) standards in a regulated biotech environment. The Senior GCP Auditor will partner closely with internal teams and external vendors to strengthen quality systems, support audit readiness, and drive timely resolution of compliance issues. The position is well suited for a detail-oriented professional who can balance documentation rigor with practical cross-functional problem solving. Location: Remote - US based candidates only, no visa sponsorship available. Compensation: $140,000 – $154,000 annually.

Responsibilities

• Maintain and update the clinical trial quality management system
• Contribute to the development and review of SOPs and controlled documents
• Ensure compliance with ICH GCP E6 (R2) standards
• Manage the incident management program, including monitoring complaints and deviations
• Conduct vendor, supplier, and clinical trial site audits
• Prepare documentation for audit activities and follow-up resolutions
• Collaborate across teams to address GCP compliance issues

Qualifications

• Bachelor's or Master's degree in life sciences or engineering
• 7+ years of experience in a GCP-biologics or pharmaceutical setting with a Bachelor's degree, or 4+ years with a Master's degree
• CQA or similar audit certification preferred
• Experience with TMF or electronic document management systems preferred
• Strong analytical skills and attention to detail

Benefits

• Comprehensive medical, dental, and vision plan options
• Employee Assistance Program (EAP)
• 401(k) retirement plan with company match
• Unlimited PTO for exempt employees
• 529 education savings program
• Wellness programs and employee discounts

Our client is an equal opportunity employer.