Senior Quality and Compliance Specialist

Summary

Join MMS, a leading data-focused CRO, as a Compliance Auditor. We support pharmaceutical, biotech, and medical device industries. You will conduct GCP audits, author audit documents, develop CAPA plans, and monitor vendors and sites. This role requires a college degree in a scientific field or equivalent experience, along with 5+ years in a GCP-regulated industry. Expertise in GCP, FDA regulations, and clinical trial processes is essential. Up to 30% travel within the US is required.

Requirements

• Be a college graduate in a scientific, medical, clinical discipline or have related experience; a Master's degree is preferred; or have a minimum of 7 years’ experience in a GCP regulated industry if not a college graduate
• Have a minimum of 5 years’ experience in a GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor)
• Possess expert knowledge of scientific principles and concepts
• Be proficient with MS Office applications
• Have good communication skills and a willingness to work with others to clearly understand needs and solve problems
• Possess excellent problem-solving skills
• Have good organizational and communication skills
• Be proficient with 21 CFR Part 11, FDA, and GxP requirements
• Possess expertise within CROs and scientific and clinical data/terminology, and the drug development process
• Be willing to travel up to 30% of the time for audits within the US

Responsibilities

• Maintain a strong understanding of regulations and guidance as they pertain to compliance; maintain knowledge relating to regulatory updates
• Understand how to plan, prepare and conduct GCP audits independently
• Be proficient in authoring and managing audit documents independently
• Develop CAPA plans and contribute to resolution of audit findings independently
• Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently
• Assist in other duties relating to overall compliance within Quality and Compliance department, as requested

Preferred Qualifications

Have hands-on experience with clinical trial and pharmaceutical development