GCP Auditor

MMS is a leading clinical research organization (CRO) that prides itself on being a Great Place to Work certified organization. We are seeking a highly skilled GCP Auditor to join our team and contribute to our mission of shaping the future of clinical research.

• Conduct vendor qualification audits and/or investigator site audits, including the creation of audit plans, reports, and debrief presentations.
• Provide vendor oversight and monitoring, as needed.
• Investigate errors and conduct risk assessments.
• Host and interact with regulatory authorities during inspections.

• Minimum 5 years of experience in GCP auditing within the CRO, Pharma, or Biotech industry.
• Bachelor's Degree in a scientific, medical, or clinical discipline.
• Travel may be required for onsite audits.
• Expert knowledge of scientific principles and concepts.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development.
• Excellent communication and problem-solving skills.
• Good organizational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 standards.
• Proficient experience with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific and clinical data/terminology, and the drug development process.

MMS is a dynamic and supportive organization that values its employees. We offer a collaborative and inclusive work environment where you can thrive and advance your career.