Gcp Auditing Consultant - Remote

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. This role is a project-based consulting opportunity.

Responsibilities:

Independently conduct vendor qualification audits and/or investigator site audits including relevant audit documents such as: audit plan, audit report and debrief presentations. Vendor oversight and monitoring, as needed. Experience with performing investigations of errors and risk assessments. Experience with hosting and interacting with regulatory authorities during an inspection.

Requirements:

Minimum 5 years of experience in GCP auditing role 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. Good communication skills and willingness to work with others to clearly understand needs and solve problems. Excellent problem-solving skills. Good organizational and communication skills. Familiarity with current ISO 9001 and ISO 27001 standards preferred. 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.

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