GCP Auditor (Contractors)

RQM+; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

RQM+ is seeking a seasoned GCP Auditor to join our Global Audit Practice on a contract basis in the United States. You will plan, conduct, and report GCP audits to assess compliance with FDA, ICH GCP, and international regulations, working with clients, sites, sponsors, CROs, and vendors.

The ideal candidate has 10+ years in clinical research or QA, strong writing and communication skills, and the ability to travel domestically and internationally.

Qualifications

• 10+ years in clinical research, clinical operations, quality assurance, GCP auditing, or a related field.
• Significant hands-on experience conducting GCP audits across multiple clinical research environments.
• Bachelor's degree in life sciences or related discipline; equivalent experience considered.
• Expert-level knowledge of ICH GCP and applicable clinical research regulations and guidance.
• Strong technical writing and audit report-writing skills.
• Excellent verbal communication, presentation, and client-facing abilities.

Responsibilities

• Plan, conduct, and report GCP audits to assess compliance with regulations, guidelines, protocols, and organizational procedures.
• Identify compliance risks, strengthen quality systems, and maintain inspection readiness across the clinical development lifecycle.
• Audit clinical trial activities including sites, sponsors, CROs, vendors, systems, and processes; communicate findings and provide practical, risk-based recommendations.

Skills

GCP auditing

Regulatory compliance

Clinical research

FDA / NB inspections

21 CFR Part 11

Risk-based auditing

Quality systems

CAPA investigations

Clinical trials management

Travel readiness

Education

Bachelor's degree in life sciences

Job description

RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients - faster, safer, better.

We don't make MedTech. We make MedTech happen.

Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.

Job Summary

To support the continued growth and expansion of our Global Audit Practice, we’re looking to connect with experienced GCP Auditors interested in partnering with RQM+ on a contract basis to conduct client audits.

NOTE: We require General Liability and Professional Indemnity insurance for all subcontractors.

Primary Responsibilities

The GCP Auditor is responsible for planning, conducting, and reporting Good Clinical Practice (GCP) audits to assess compliance with applicable regulations, guidelines, protocols, and organizational procedures. This role supports clients in identifying compliance risks, strengthening quality systems, and maintaining inspection readiness throughout the clinical development lifecycle.

The GCP Auditor will conduct audits of clinical trial activities, including clinical sites, sponsors, CROs, vendors, systems, and processes. The role requires strong knowledge of GCP requirements, clinical research operations, risk-based auditing principles, and applicable global regulatory expectations.

The ideal candidate is an experienced clinical research or quality professional who can independently execute audits, effectively communicate findings, and provide practical, risk-based recommendations to clients and internal stakeholders.

Required Experience Areas

• Clinical investigation auditing (sponsor, CRO, and site audits, IRBs, Clinical Vendors)
• Risk-based quality management and clinical quality systems
• CAPA and root cause investigation within clinical research
• Auditing electronic records and electronic signatures (21 CFR Part 11)
• Clinical evaluations conducted in accordance with EU MDR 2017/745
• Supporting or auditing FDA inspections or Notified Body inspections (preparation for FDA / NB Inspections and/or support during Inspections)
• Investigator-sponsored studies (ISSs) and post-market clinical follow-up (PMCF) studies
• Therapeutic-area expertise relevant to Client's portfolio (e.g., cardiology, imaging, monitoring, software/AI), if applicable

Required Standards And Regulations

• ISO 14155:2026
• EU MDR clauses (62-82) and Annexes for clinical investigations (Annex XV)
• 21 CFR Parts 812, 50, 54, 56, and 11
• FDA Bioresearch Monitoring (BIMO)
• ICH E6 Good Clinical Practice (GCP)

Education/Work Experience/Requirements

• 10+ years of experience in clinical research, clinical operations, quality assurance, GCP auditing, or a related field.
• Significant hands-on experience conducting GCP audits, preferably across multiple types of clinical research organizations and environments.
• Bachelor's degree in life sciences, healthcare, nursing, pharmacy, clinical research, or a related discipline; equivalent relevant experience may be considered.
• Expert-level knowledge of ICH GCP and applicable clinical research regulations and guidance.
• Strong understanding of FDA regulations and experience with international GCP requirements.
• Demonstrated ability to independently lead complex GCP audits from planning through final report and follow-up.
• Experience evaluating clinical trial processes, documentation, systems, and quality controls.
• Demonstrated ability to identify, assess, and articulate significant compliance risks.
• Strong technical writing and audit report-writing skills.
• Excellent verbal communication, presentation, and client-facing skills.
• Ability to exercise independent judgment and make sound, risk-based decisions.
• Strong organizational and project management skills with the ability to manage multiple engagements simultaneously.
• Willingness and ability to travel domestically and internationally as required.

Behaviors:

Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Supervisory Responsibilities:

None.

Work Environment & Physical Requirements

This role involves regular travel to client and partner sites, which may include varying office and facility environments. The employee should be able to travel independently, navigate different facility types, and occasionally lift or carry items up to 25 lbs (e.g., equipment, materials, luggage).

These requirements reflect what's typically needed to perform the core functions of this role. If you require an accommodation to perform any aspect of this position, please let us know - we're happy to discuss options.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

Job Opportunity Verification

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

• All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
• Every candidate going through the interview process will participate in a voice and/or video interview.
• Exercise caution with unsolicited job offers or requests for sensitive information.