GCP Auditor

 RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

To help support our ever growing and expanding Global Audit Practice, we’re interested in speaking to Auditors who would be interested in supporting RQM on various supplier/vendor audits on a contract basis for our clients in the U.S. These will be a mixture of on-site and remote desktop audits.

Primary Responsibilities

• The candidate will be responsible for project management, audit planning, executing the audit within the allotted time, issuing the audit report within the allotted time and the approval of the final audit report.
• The candidate will be capable of providing the clients with 80% auditor (hats on) and 20% mentor (hats off).
• The candidate will be responsible for identifying opportunities where RQM+ can provide additional support and assistance to the client. These opportunities shall be fed back the RQM+ business development team.
• The candidate will be responsible for supporting the training and development of junior auditors, providing them with guidance and support.
• The candidate will be responsible for identifying and supporting the development of training modules required by the Audit Practice.
• The candidate will be responsible for maintaining their training in new / revised regulations, standards and guidances as they become available.
• This is a client facing role and the candidate must have the quiet authority and confidence to arrange and host client meetings and conduct the audits.
• As an auditor there will be challenging situations and difficult conversation with the client. The candidate must have the strength of character to manage these situations with tact, diplomacy and integrity. Admit when they are wrong and maintain their position when they are right.

Requirements

• A professional and qualified Medical Device lead auditor, with 10+ years of experience in the Clinical Research (specifically, Medical Device) industry.
• Expertise in Good Clinical Practice must include 21 CFR, ISO14155, ICH GCP
• Expertise in FDA BIMO Audit expectations is highly desirable.
• ISO20916 and EU IVDR are also highly desirable.
• Robust auditing experience.
• A university degree, or equivalent in science or nursing. 

Behaviours

• Maintain the highest level of integrity
• Laser focused on customer success
• Improve all the time
• Communicate effectively and proactively
• Be courageous, proactive, and figure it out to achieve the highest level of success
• Operate as a cohesive team…. that likes to have fun
• Share concerns and follow-up with a thoughtful solution
• Lives by the Golden Rule – treat others as you would like to be treated

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.