Lead Quality Assurance and Compliance Analyst

2 weeks ago


Dundalk, Maryland, United States MMS Full time
Position Overview

Are you eager to become part of an organization where your efforts are valued, and where you will collaborate with a dynamic and innovative team? MMS is a distinguished, data-centric clinical research organization (CRO) recognized for its outstanding workplace culture and exceptional employee retention. We provide support to the pharmaceutical, biotechnology, and medical device sectors through our established, scientific methodologies for navigating complex trial data and regulatory submission challenges. With a presence across four continents, MMS not only boasts an industry-leading customer satisfaction rating but also cultivates a collaborative and inclusive environment where team members can excel.

Join MMS and contribute to a team that is influencing the future of clinical research.


Key Responsibilities:
  • Maintain a comprehensive understanding of regulations and guidelines relevant to compliance; stay informed about regulatory updates.
  • Independently review and edit Quality Management System (QMS) documents, including Standard Operating Procedures (SOPs), Work Practices, Forms, and Training Materials.
  • Oversee vendors and clinical investigator sites to ensure adherence to processes and maintenance of quality standards independently.
  • Lead and manage various projects effectively.
  • Assist with additional tasks related to overall compliance within the Quality and Compliance department as needed.
  • Willingness to travel up to 20% for client engagements within the United States.
Qualifications:
  • Bachelor's degree in a scientific, medical, or clinical discipline, or a minimum of 7 years of experience in a Good Clinical Practice (GCP) regulated environment if a degree is not held.
  • At least 5 years of experience in a GCP regulated industry (e.g., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor).
  • In-depth knowledge of scientific principles and concepts.
  • Proficient in Microsoft Office applications.
  • Hands-on experience in clinical trials and pharmaceutical development is preferred.
  • Strong communication skills and a collaborative approach to understanding needs and resolving issues.
  • Familiarity with 21 CFR Part 11, FDA regulations, and GxP requirements.
  • Expertise in CRO operations, scientific and clinical terminology, and the drug development process.

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