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 help support our growing and expanding Global Audit Practice, we’re interested in speaking to GCP Auditors who would be interested in supporting RQM+ with client audits on a contract basis for our clients in the U.S.

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.

Education/Work Experience/Requirements:

• 10+ years of experience in clinical research, clinical operations, quality assurance, GCP auditing, or a related field.
• ISO 14155:2026 experience
• EU MDR 2017/745 experience
• 21 CFR Parts 11, 50, 54, 56, 812, 814, and 820 experience
• 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!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

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.