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    Compliance / Business Risk Officer - England, United Kingdom - Johnson & Johnson

    Johnson & Johnson
    Johnson & Johnson England, United Kingdom

    2 weeks ago

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    Description
    Job Description - Local Compliance Specialist W)
    Local Compliance Specialist W
    Local Compliance Specialist
    At Johnson & Johnson, we believe health is everything.

    Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

    We are looking for a clinical research professional with a passion for quality.

    The Compliance Specialist will be responsible for performing activities that ensure we conduct clinical trials to the required legal and quality standards.

    You can be based at home or in the office.

    This exciting role includes performance of QC checks, audit and inspection support (preparation and responses), quality issue management (root cause analysis and CAPA development) including UK serious breach, identification and mitigation of risk, management of local SOPs, delivery of training on processes, regulations and quality, oversight of local vendors, and provision of a GCP Helpdesk service.

    The role will work closely with UK Local Trial Managers and Site Managers (CRAs) to support inspection readiness across our clinical trial portfolio.

    The role also requires collaboration across other local and global functions.
    You should be flexible and be able to work independently.

    You will be part of a hard-working and committed local compliance team who provide quality leadership across all therapeutic areas and phases of in-house trials in the UK.

    This role will suit someone with broad clinical research experience, working knowledge of GCP and the UK regulatory environment, and a dedication to quality.

    Quality and Compliance Oversight Activities
    Monitor compliance risk and ensure mitigation/remediation actions are defined following effective root cause assessment. Perform and report QC checks and compliance assessments such as On-Site Compliance Monitoring Visits, reviews of Trial Master File, planning and execution of local QC checks, support local and central study teams in root cause analysis of significant observations
    Collaborate with business partners to facilitate (local) regulatory inspections and site/office audits
    Collaborate with local and central business partners in timely CAPA setting and implementation.
    Develop and manage local procedural documents/SOPs
    Coordinate local supplier assessments
    Local Onboarding and Consultation
    Support and deliver local training on quality related topics
    Provide advice to the local team on process, system, and GCP-related questions
    Local regulatory intelligence
    ~ Maintain knowledge of the UK clinical research regulations and perform impact assessments of new/revised local regulations and guidance

    Site Manager (CRA)/Local Trial Manager roles) and/or quality assurance.
    Developed skills and knowledge of business processes and practices (i.e., Experience in audit and/or inspection process, and systems and vendors, is an asset
    Highly committed to quality and compliance
    Flexible and persistent

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

    All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.

    If you are an individual with a disability, please check ourpage for information on how to request an accommodation.
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