Senior Quality and Compliance Specialist

MMS

. Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates .

Posted 4/21/2026full-timeRemote • Missouri • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates
Understanding of how to plan, prepare and conduct GxP audits independently
Ability to support clients with development or refinement of Quality Management Processes or Systems
Project management as it relates to quality and compliance activities
Proficient in authoring and managing audit documents independently
Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently
Assists in other duties relating to overall compliance within Quality and Compliance department, as requested
Must be willing to travel up to 30% of the time for audits within the US; must also be willing to travel internationally as needed

Requirements

What you’ll need

College graduate in scientific, medical, clinical discipline or related experience, Masters preferred
Minimum of 7 years’ experience in GCP regulated industry if not a college graduate
Minimum of 5 to 7 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor)
Expertise within CROs, scientific and clinical data/ terminology, and the drug development process
Experience with project oversight including but not limited to; document management, vendor qualifications, training management
Proficiency with MS Office applications
Hands-on experience with clinical trial and pharmaceutical development preferred
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
Proficient with applicable regulatory requirements
Must have strong technical writing skills

Benefits

Comp & perks

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Hard Skills & Tools

GxP auditsQuality Management ProcessesQuality Management Systemsaudit document managementproject managementclinical trial developmentregulatory compliancetechnical writingdocument managementvendor qualifications

Soft Skills

communication skillsproblem-solving skillsorganizational skillscollaborationindependence