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Gcp Auditor Jobs (NOW HIRING)

Merican

GCP Auditor, Quality Assurance

Paramus, NJ · On-site

GCP Auditor, Quality Assurance Location: Paramus, NJ, 07652 Job Type: Temporary Assignment Duration: 6+ Months Work Type: Onsite Shift: Mon-Fri 9.00 AM-5.00 PM * The GCP Quality Assurance Auditor ...

ImmunityBio, Inc.

Senior GCP Auditor

$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 ...

ImmunityBio

Senior GCP Auditor

Culver City, CA · On-site +1

$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 ...

Genstar Capital LLC

Auditors support compliance reviews across GCP clinical sites and vendors. Job Duties & Responsibilities * Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and ...

Abbott

Senior Auditor Clinical Affairs

Lake Forest, IL · On-site

$80K - $98K/yr

Maintains current knowledge of applicable FDA regulations, ICH GCP,FDA regulations and other applicable regulatory standards to maintain effectiveness as an Clinical Affairs Auditor. * Conducts ...

New

Abbott

Senior Auditor Clinical Affairs

Lake Forest, IL · On-site

$80K - $98K/yr

Maintains current knowledge of applicable FDA regulations, ICH GCP,FDA regulations and other applicable regulatory standards to maintain effectiveness as an Clinical Affairs Auditor. * Conducts ...

Abbott

Senior Auditor Clinical Affairs

Lake Forest, IL · On-site

$80K - $98K/yr

Maintains current knowledge of applicable FDA regulations, ICH GCP,FDA regulations and other applicable regulatory standards to maintain effectiveness as an Clinical Affairs Auditor. * Conducts ...

UCB

Global Quality Auditing Lead REMS/GCP

Raleigh, NC · Hybrid

Perform GCP audits of potential new vendors/partners for purposes of qualification prior to ... ISO 9001 lead auditor certification as a nice to have, etc.) Internal applicants should be in their ...

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How much do gcp auditor jobs pay per year?

As of Jun 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 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 are the key skills and qualifications needed to thrive in the Gcp Auditor position, and why are they important?

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 is a GCP Auditor job?

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.

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What cities are hiring for Gcp Auditor jobs? Cities with the most Gcp Auditor job openings:
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Gcp Auditor jobs near you
Infographic showing various Gcp Auditor job openings in the United States as of June 2026, with employment types broken down into 33% Full Time, 33% Temporary, and 34% Contract. Highlights an 100% In-person job distribution, with an average salary of $92,797 per year, or $44.6 per hour.
GCP Auditor, Quality Assurance

GCP Auditor, Quality Assurance

Merican

Paramus, NJ • On-site

Other

Posted 11 days ago

Job description

Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.
Job Title: GCP Auditor, Quality Assurance
Location: Paramus, NJ, 07652
Job Type: Temporary Assignment
Duration: 6+ Months
Work Type: Onsite
Shift: Mon-Fri 9.00 AM-5.00 PM
Job Description:
  • The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance.
  • This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company's compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits.
  • This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials.
  • The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates.
  • The ideal candidate will have extensive GCP experience.
  • This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies.
  • They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance

Requirements:
  • 2+ years of pharmaceutical experience
  • BS degree in scientific, health care or related discipline
  • Intensive GCP and safety background
  • Experience with both internal and external process and systems audits
  • Strong knowledge of development policies, procedures and standards (SOPs, QMS)
  • Ability to work with global clinical teams in developing objectives for audits of clinical studies
  • 10% Traveling required

TASKS AND RESPOSIBILITIES:
  • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials.
  • Plan and conduct audits of specific clinical processes based on risk.
  • Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor.
  • Develop audit reports and distribute them to appropriate stakeholders
  • Own and manage related clinical vendor non-conformances.
  • Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.).
  • Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors.
  • Support the preparation, coordination, and participation of regulatory agency inspections.
  • Participate in and support quality improvement projects.
  • Candidates MUST HAVE 2+ years of radiopharmaceuticals and quality experience.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.
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About Merican

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Merican is a IT Service consulting firm, specialized in Digital adoption and Business automation. With our diverse collection of skilled and committed consultants, technology companies, businesses and digital experts, we provide our subject expertise and our unique client service approach, a best-in-class global model of delivery suited to the business demands of our clients. We ensure that we implement future-oriented solutions for our clients via investments in people, solutions, technologies, competencies and infrastructure.

Industry

It services

Company size

51 - 200 Employees

Headquarters location

Columbia , MD, US

Year founded

2020

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