San Francisco, CA · On-site
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
San Francisco, CA · On-site
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
San Francisco, CA · On-site
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
San Francisco, CA · On-site
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
San Francisco, CA · On-site
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
San Francisco, CA · On-site
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
San Francisco, CA · On-site
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
San Francisco, CA · On-site
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
San Francisco, CA · On-site
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
San Francisco, CA · On-site
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
Mariposa, CA · On-site
$84K - $103K/yr
Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This ...
Mariposa, CA · On-site
$84K - $103K/yr
Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This ...
El Segundo, CA · On-site
ICH GCP E6 (R2) Compliance * Clinical Trial Auditing * SOP Development * Incident Management * CQA Certification ATS Optimization Keywords Hard Skills * Clinical Trial Quality Management * SOP ...
New
El Segundo, CA · On-site
ICH GCP E6 (R2) Compliance * Clinical Trial Auditing * SOP Development * Incident Management * CQA Certification ATS Optimization Keywords Hard Skills * Clinical Trial Quality Management * SOP ...
New
El Segundo, CA · On-site
$86K - $106K/yr
Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This ...
El Segundo, CA · On-site
$86K - $106K/yr
Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This ...
Culver City, CA · On-site
$88K - $108K/yr
Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This ...
Culver City, CA · On-site
$88K - $108K/yr
Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This ...
El Segundo, CA · On-site
$86K - $106K/yr
Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This ...
El Segundo, CA · On-site
$86K - $106K/yr
Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This ...
El Segundo, CA · On-site
$86K - $106K/yr
Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This ...
El Segundo, CA · On-site
$86K - $106K/yr
Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This ...
$82K - $101K/yr
Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This ...
$82K - $101K/yr
Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This ...
Center Square, PA · On-site
Strong knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations). * Excellent analytical and problem-solving skills, with the ability to identify ...
New
Center Square, PA · On-site
Strong knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations). * Excellent analytical and problem-solving skills, with the ability to identify ...
New
King Of Prussia, PA · On-site
The Opportunity This role serves as a GCP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of clinical trial ...
King Of Prussia, PA · On-site
The Opportunity This role serves as a GCP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of clinical trial ...
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
New
Quick apply
... across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is ...
New
Plan, execute, report routine or directed GCP audits (e.g., investigator site, vendor, internal ... of contract auditor assignments, as assigned Other duties as assigned Qualifications Required ...
Plan, execute, report routine or directed GCP audits (e.g., investigator site, vendor, internal ... of contract auditor assignments, as assigned Other duties as assigned Qualifications Required ...
South San Francisco, CA · On-site
$165K - $207K/yr
Develop/review/maintain SOPs and quality documents for GCP auditing and compliance. * Manage the internal GCP audit program (planning, execution, follow-up, effectiveness). * Support mock and ...
South San Francisco, CA · On-site
$165K - $207K/yr
Develop/review/maintain SOPs and quality documents for GCP auditing and compliance. * Manage the internal GCP audit program (planning, execution, follow-up, effectiveness). * Support mock and ...
$38.5K - $48.7K
3% of jobs
$48.7K - $59K
11% of jobs
$59K - $69.2K
8% of jobs
$72.5K is the 25th percentile. Wages below this are outliers.
$69.2K - $79.4K
11% of jobs
The median wage is $88.3K / yr.
$79.4K - $89.6K
20% of jobs
$89.6K - $99.9K
13% of jobs
$108K is the 75th percentile. Wages above this are outliers.
$99.9K - $110.1K
12% of jobs
$110.1K - $120.3K
11% of jobs
$120.3K - $130.5K
9% of jobs
$130.5K - $140.8K
3% of jobs
$140.8K - $151K
0% of jobs
$38.5K
$92.8K
$151K
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.
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.
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.
Cities with the most Gcp Auditor job openings:
The most popular types of Gcp Auditor jobs are:
States with the most job openings for Gcp Auditor jobs include:
For Gcp Auditor jobs, the most frequently searched job titles are:
San Francisco, CA • On-site
Full-time
Posted 4 days ago
Medicine moves forward here. So will you.
ADAMAS Consulting helps the world's pharmaceutical and biotechnology companies uphold the highest standards of quality, compliance and patient safety. Since 2007 we have partnered with organizations across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences.
We think of our work as more than auditing. At its best it is intelligence: helping clients see the compliance risks that matter most and prevent the problems that could put patients at risk. That takes sharp, independent thinking and deep expertise, which is exactly what our people bring.
Here your knowledge is valued and shared, not kept in silos. We have built a supportive, collaborative environment where professional growth is encouraged and where you can make a real impact across the industry, working alongside some of the most respected companies in the field.
Planning, preparation, conduct, reporting and follow up of various types of GCP audits according to expected quality and timelines
Executing audits based on a comprehensive understanding of all regulatory requirements and Good Clinical Practice (GCP).
Performing GCP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
BSc in Life Science preferred
Experience in conducting and leading internal and external GCP audits for a variety of stakeholders
Experience in conducting a range of service provider audits (e.g., full-service CRO, biostatistics, data management, phase I)
Experience in conducting GCP systems audits.
Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site.
Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage.
Expert knowledge of national and international GCP legislation and guidelines
Up to 40% travel and ability to conduct remote audits
Why ADAMAS?
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You'll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
Quality: we hold ourselves to the standard patients deserve.
Integrity and trust: we do the right thing, especially when it is hard.
Drive and passion: we care about the outcome, because someone is waiting on it.
Agility and responsiveness: we move quickly, because patients cannot wait.
Belonging: everyone is welcome, and every voice counts.
Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.
Sourced by ZipRecruiter
Medical equipment and supplies manufacturing
1 - 10 Employees
San Antonio, TX, US
1987
