MMS · 2 days ago
Senior Quality and Compliance Specialist (Remote)
United States
Full-time
Remote
Senior Level
5+ years expMMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries. They are seeking a Senior Quality and Compliance Specialist to maintain a strong understanding of regulations and guidance, conduct GxP audits, and support clients with Quality Management Processes.
BiotechnologyHealth CareLife Science
Responsibilities
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
Qualification
Required
College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or 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
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
Preferred
Hands-on experience with clinical trial and pharmaceutical development
Company
MMS
MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
501-1000 employees
H1B Sponsorship
MMS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (2)
2022 (8)
2021 (9)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Lindsay Goldberg
2022-06-28Private Equity
Leadership Team
Christopher Schoonmaker
Chief Operating Officer
Kevin Chartier
Principal Advisor, Biostatistics and Submission Planning
Recent News
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