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Gcp Auditor Jobs (NOW HIRING)

Labcorp

Lead Internal Auditor, GLP/GCP

Indianapolis, IN · On-site

Labcorp is seeking a Lead Internal Auditor, GLP/GCP to join our team in Indianapolis, IN ! Work Schedule: Monday Through Friday 8-5 pm Job Responsibilities: The Lead Internal Auditor plays a pivotal ...

Labcorp

Lead Internal Auditor, GLP/GCP

Indianapolis, IN · On-site

Labcorp is seeking a Lead Internal Auditor, GLP/GCP to join our team in Indianapolis, IN ! Work Schedule: Monday Through Friday 8-5 pm Job Responsibilities: The Lead Internal Auditor plays a pivotal ...

Labcorp

Quality Auditor - GLP/GCP

Indianapolis, IN · On-site

Labcorp is seeking a Quality Auditor, GLP/GCP to join our team in Indianapolis, IN Work Schedule: Monday Through Friday 8-5 pm Job Responsibilities: The Quality Auditor plays a pivotal role as part ...

Labcorp

Quality Auditor - GLP/GCP

Indianapolis, IN · On-site

Labcorp is seeking a Quality Auditor, GLP/GCP to join our team in Indianapolis, IN Work Schedule: Monday Through Friday 8-5 pm Job Responsibilities: The Quality Auditor plays a pivotal role as part ...

Labcorp

Quality Auditor - GLP/GCP

Indianapolis, IN · On-site

Labcorp is seeking a Quality Auditor, GLP/GCP to join our team in Indianapolis, IN Work Schedule: Monday Through Friday 8-5 pm Job Responsibilities: The Quality Auditor plays a pivotal role as part ...

Labcorp

Quality Auditor - GLP/GCP

Indianapolis, IN · On-site

Labcorp is seeking a Quality Auditor, GLP/GCP to join our team in Indianapolis, IN Work Schedule: Monday Through Friday 8-5 pm Job Responsibilities: The Quality Auditor plays a pivotal role as part ...

International Executive Service Corps

Additional Qualifications Experience with clinical quality documentation systems, document review, and GCP auditing responsibilities is required. Comprehensive knowledge of ICH-GCP, applicable global ...

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How much do gcp auditor jobs pay per year?

As of Sep 14, 2026, the average yearly pay for gcp auditor in the United States is $92,797.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,000.00 and $112,000.00 per year, depending on experience, location, and employer.

What is a GCP auditor?

A GCP (Good Clinical Practice) Auditor is responsible for ensuring that clinical trials comply with regulatory guidelines, ethical standards, and company policies. They conduct audits of clinical trial sites, processes, and documentation to verify compliance with regulations such as ICH-GCP and FDA guidelines. GCP Auditors identify potential risks, report findings, and recommend corrective actions to maintain data integrity and patient safety. Their role helps ensure that clinical research is conducted with high-quality standards and meets regulatory requirements for drug approval.

What are the key skills and qualifications needed to thrive as a GCP auditor?

To thrive as a Gcp Auditor, you need extensive knowledge of Good Clinical Practice (GCP) guidelines, clinical research processes, regulatory requirements, and typically a background in life sciences or a related field. Familiarity with audit management tools, clinical trial management systems (CTMS), and certifications such as RQA or ASQ Certified Quality Auditor are often advantageous. Strong analytical thinking, attention to detail, excellent communication, and interpersonal skills allow Gcp Auditors to effectively assess processes and interact with diverse stakeholders. These skills are crucial to ensure clinical trials comply with global standards, safeguard patient safety, and maintain data integrity.

What are some common challenges GCP auditors encounter in their work, and how are they addressed?

Gcp Auditors often face challenges such as navigating complex international regulations, keeping up with frequent changes in industry standards, and effectively assessing diverse clinical trial environments. To overcome these, auditors maintain ongoing training, leverage audit checklists and standardized procedures, and collaborate closely with clinical study teams to clarify requirements and expectations. Regular communication and strong organizational skills help auditors stay prepared for unexpected findings and ensure thorough documentation. This proactive approach helps maintain the integrity of clinical trials and fosters a culture of continuous improvement.

What cities are hiring for Gcp Auditor jobs?

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What are the most commonly searched types of Gcp Auditor jobs?

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Gcp Auditor jobs near you
Infographic showing various Gcp Auditor job openings in the United States as of September 2026, with employment types broken down into 94% Full Time, 2% Part Time, and 4% Contract. Highlights an 74% Physical, 6% Hybrid, and 20% Remote job distribution, with an average salary of $92,797 per year, or $44.6 per hour.

Director, GCP Quality Assurance

San Diego, CA • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 6 days ago

Job description

Position Summary

The Director, GCP Quality Assurance leads Good Clinical Practice (GCP) audit activities across the clinical development portfolio to ensure compliance with global regulatory requirements and internal quality standards. Provides strategic oversight of GCP quality systems, manages audit programs, supports inspection readiness, and serves as a GCP compliance subject matter expert.

Primary Responsibilities
  • Plan, schedule, conduct, and manage internal/external GCP audits of CSPs, CROs, investigator sites, and vendors
  • Prepare/review/finalize audit reports; document observations, risks, and corrective actions; track to resolution
  • Develop/review/maintain GCP Quality Agreements with CROs, CSPs, and clinical study partners
  • Maintain GCP audit metrics and deliver quality/compliance reporting for management reviews and continuous improvement
  • Develop/review/maintain SOPs and quality documents supporting GCP auditing and compliance
  • Manage internal GCP audit program (planning, execution, follow-up, and effectiveness assessments)
  • Support mock and regulatory inspections and responses for GCP studies/quality systems
  • Provide GCP compliance guidance to cross-functional stakeholders to ensure adherence to FDA, ICH, EU, and other global requirements
  • Recommend and implement improvements to GCP quality systems, processes, and procedures
Education & Experience (Required)
  • Bachelor’s in Life Sciences or related field (or equivalent education/experience)
  • 10+ years in pharmaceutical/biotech/regulated industry
  • 5+ years in GCP Quality Assurance, compliance, and auditing
  • Lead Auditor experience for internal/external GCP audits
  • Strong knowledge of ICH-GCP and applicable FDA/EU/international GCP regulations
  • Audit experience covering CROs, investigator sites, and GCP service providers
  • Experience supporting regulatory inspections/inspection readiness
Preferred Qualifications
  • SQA/ASQ/Lead Auditor certification
  • Experience conducting global audits across US/EU/UK/Japan and other regions
  • Experience with eCOA, CSV, and data management
Benefits (as stated)
  • Medical, dental, vision; 401(k) match 1:1 up to 5%; equity; bonus; life/disability/EAP; tuition assistance; paid time off; paid parental leave; sick time.
Physical/Other
  • Ability to travel overnight independently and work after hours if required.
  • Occasionally lift/move up to 15 pounds.
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