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

    MMS
    MMS Seattle, United States

    3 hours ago

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    Description

    Job Description

    MMS is a forward-thinking CRO specialized in handling data for the pharmaceutical, biotech, and medical device sectors. Our scientific approach tackles complex trial data and regulatory submission challenges, setting us apart as a valuable CRO partner. Operating globally across four continents, we have maintained a stellar 97% customer satisfaction rating. MMS has been consistently honored as a top CRO in Global Health & Pharma's international awards programs for the past three years.



    Job Specific Skills:
    • Maintains a strong understanding of regulations and guidance for compliance, staying updated on regulatory changes.
    • Proficient in planning, executing GCP audits independently.
    • Skilled in creating and managing audit documents autonomously.
    • Experience in reviewing and editing QMS documents independently.
    • Capable of developing CAPA plans and aiding in resolving audit findings independently.
    • Monitors vendors and clinical investigator sites to ensure adherence to processes and quality independently.
    • Supports overall compliance within the Quality and Compliance department as needed.
    • Willingness to travel up to 75% of the time for audits in the US and potentially in Canada.
    Requirements:
    • College graduate in scientific, medical, clinical discipline or equivalent experience, Master's degree preferred; or a minimum of 7 years' experience in the GCP regulated industry for non-college graduates.
    • Minimum of 5 years' experience in the GCP regulated industry (e.g., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.)
    • Expertise in scientific principles and concepts.
    • Established reputation as a leader in the field with consistent performance and achievements.
    • Familiarity with MS Office applications.
    • Hands-on experience in clinical trials and pharmaceutical development is desirable.
    • Strong communication skills and a collaborative mindset to understand requirements and solve problems effectively.
    • Excellent problem-solving abilities.
    • Solid organizational and communication skills.
    • Proficiency in 21 CFR Part 11, FDA, and GxP requirements.
    • Experience in CROs, scientific and clinical terminology, and the drug development process.
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