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Zionsville

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

    MMS
    MMS Zionsville, United States

    2 days ago

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    Description

    Job 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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