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Senior Quality and Compliance Specialist

4 months ago

Tampa, United States MMS Full time
Job DescriptionJob Description

MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

Job Specific Skills:

  • 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 GCP audits independently.
  • Proficient in authoring and managing audit documents independently.
  • Experience in reviewing and editing QMS related documents, i.e., SOPs, Work Practices, Forms, Training Materials, etc. 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.
  • Assists in other duties relating to overall compliance within Quality and Compliance department, as requested.
  • Must be willing to travel up to 75% of the time for audits within the US and potential travel to Canada.
Requirements:
  • 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 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.)
  • Expert knowledge of scientific principles and concepts. 
  • Reputation as emerging leader in field with sustained performance and accomplishment.
  • 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 21 CFR Part 11, FDA, and GxP requirements.
  • Expertise within CROs and scientific and clinical data/ terminology, and the drug development process.

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