Senior Quality and Compliance Specialist - Aurora, United States - MMS

MMS Aurora, United States

3 weeks ago

Description

Job 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 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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