Global Regulatory Affairs Quality - Parma - Chiesi USA, Inc.

    Chiesi USA, Inc.
    Chiesi USA, Inc. Parma

    1 settimana fa

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    Descrizione

    Global Regulatory Affairs Quality & Process Specialist - Temporary

    This is a summary of the job description.

    Job Description:

    We are seeking a skilled Global Regulatory Affairs Quality and Process Specialist to join our team on a temporary basis.

    Main Responsibilities:

    • Oversee GRA quality system documentation, maintenance, and compliance activities including ensuring compliant training plans are created, applied, and maintained throughout GRA.
    • Manage GRA related deviations and correction action and preventive action plans (CAPA) as needed.
    • Ensure GRA Manual, Standard Operating Procedure (SOP), and Working Instruction (WI) implementation and continuous improvement.
    • Establish and ensure cross-functional (GPV, GMD, and GCD) communication flows related to GRA activities.
    • Oversee audit and inspection related activity, including coordination of pre-audit/inspection activities and participation in audits/inspections as needed.
    • Ensure GRA Key Performance Indicators (KPIs) are provided in a timely manner.
    • Provide process-related support for GRA projects including impact assessment of quality documents and process mapping.
    • Oversee Regulatory operational activities for the Therapeutic Areas (TAs) ensuring appropriate cross-functional support is provided.
    • Manage and promote appropriate communication on GRA Quality and Process related activities/projects and HA regulations.

    Experience Required:

    A minimum of 5 years experience in Regulatory Affairs. In-depth knowledge of drug development and regulatory procedures.

    Education:

    Life science degree.

    Languages:

    English fluent.

    Technical Skills:

    Knowledge of Regulatory Affairs procedures and deep knowledge of the full drug development process, regulatory legislation, and quality requirements.

    Soft Skills:

    • Communication skills
    • Digital mindset
    • Planning and organizational skills
    • Strategic thinking
    • Team working

    About Chiesi USA, Inc:

    Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000 employees. To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops, and markets innovative drugs in its main therapeutic areas. We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards.

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