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    Quality And Compliance Lead- Shanghai

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    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 8, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    About ICON plc

    ICON plc is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. We are committed to shaping the future of clinical development and delivering life-changing solutions. Our people are at the heart of everything we do, and we’re looking for passionate individuals to join our team and help drive excellence in clinical research.

    Role Overview

    As a Quality and Compliance Lead, you will play a pivotal role in ensuring ICON maintains the highest standards of quality and compliance within our clinical research operations. You will act as the compliance expert, overseeing quality management systems and regulatory inspection support, and implementing corrective and preventive action processes. Your expertise will help guide teams to deliver top-quality service while ensuring compliance with industry standards and regulatory requirements.

    Key Responsibilities

    • Compliance Expert:

      • Lead compliance initiatives, ensuring adherence to regulatory standards, company policies, and best practices within clinical research operations.
      • Act as the primary expert on GCP (Good Clinical Practice), pharmacovigilance, and other key regulatory requirements.

    • Quality Improvement:

      • Champion continuous quality improvement efforts, identifying areas for improvement and driving initiatives to optimize clinical processes.
      • Ensure the Quality Management Systems (QMS) are effective and compliant with internal standards and regulatory guidelines.

    • CRO Quality Management:

      • Oversee Contract Research Organization (CRO) quality management, ensuring external partners and vendors meet the company’s quality standards.

    • Regulatory Inspection Support:

      • Provide expert support during regulatory inspections (e.g., FDA, EMA, etc.), ensuring all regulatory documents are up to date and inspection-ready.
      • Coordinate preparation for audits and inspections and act as the liaison between regulatory bodies and internal teams.

    • Corrective and Preventive Action Process:

      • Lead the CAPA (Corrective and Preventive Action) process, addressing non-compliance issues and ensuring continuous improvement in clinical operations.

    What You’ll Bring

    • Qualifications:

      • Bachelor’s, Master’s, or Doctoral Degree in Medicine, Pharmaceutics, or a related field.

    • Experience:

      • Significant experience in quality management and compliance systems within the clinical research industry, particularly in GCP and pharmacovigilance.
      • In-depth understanding of medicine processes in product development and post-approval stages.

    • Skills:

      • Proficient in business-critical compliance and quality management processes.
      • Strong leadership and communication skills, with the ability to work cross-functionally to enforce compliance standards.

    Why ICON?

    At ICON, we recognize that our success depends on the knowledge, capabilities, and quality of our people. We offer a comprehensive and competitive reward package, including:

    • Excellent base pay and variable pay programs.
    • Best-in-class employee benefits and supportive policies to ensure your well-being and work-life balance.
    • A culture of continuous learning where we offer career development opportunities to enhance your professional growth.

    Diversity and Inclusion

    ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    If you need reasonable accommodations due to a medical condition or disability during any part of the application process, please let us know, and we will make the necessary arrangements.

    Interested in the Role?

    If you're unsure whether you meet all the qualifications, we encourage you to apply anyway! We’re looking for talented individuals who are eager to grow and contribute to ICON's mission.

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