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    Associate Director - United Kingdom - BeiGene, Ltd.

    BeiGene, Ltd.
    BeiGene, Ltd. United Kingdom

    2 weeks ago

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    Description

    Apply locations United Kingdom Basel time type Full time posted on Posted 2 Days Ago job requisition id R23111 BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.

    When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

    Reporting to the Director, Global GCP Inspection Excellence, the inspection lead will be primarily responsible for GCP Health Authority inspection readiness for cross-functional clinical study teams, managing inspection logistics and process improvements to ensure research and development activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices.

    Supervise and manage activities related to inspection readiness, leading inspections conducted by regulatory health authorities such as FDA, EMA, CFDI, MFDS, PMDA, TGA, etc.

    Manage Inspection Readiness Checklist, development of storyboards, identify and mitigate inspection risks, and facilitate/lead mock and actual inspections.
    Create/revise appropriate SOPs and tools for inspection readiness and management.
    Implement and maintain key QA systems, including investigations, Significant Quality Events (SQEs), Deviations, and CAPAs.
    Proven ability to set strategies for and drive initiatives aimed at improving quality processes.

    Minimum of 7 years of experience in GCP-related Quality Assurance function of the pharmaceutical, biotechnology or related health care industry.

    High level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries.
    Excellent English language skills, and additional language depending on locations and need, e.g., /. Spanish for LATAM, German, French, etc., Quality Assurance
    Medical Monitors
    Regulatory Affairs


    Travel:
    Flexible to travel, including international.
    May require up to 35% travel, sometimes with short notice time.

    When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

    Analytical Thinking/Data Analysis
    Financial Excellence
    We are proud to be an equal opportunity employer and we value diversity.

    BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.

    locations United Kingdom time type Full time posted on Posted 2 Days Ago BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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