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    Senior/Manager - Data Management, Resilience - United Kingdom - OPEN Health Group

    OPEN Health Group
    OPEN Health Group United Kingdom

    1 week ago

    Default job background
    Description
    Manager, Quality and Compliance
    Reports to Associate Director/Director, Quality and Compliance

    Our Manager, Quality and Compliance works closely with the Associate Director and the Evidence and Access (E&A) Senior Leadership Team in the implementation of quality objectives across the organization.

    They facilitate high-quality and compliant delivery of Health Economic Outcomes Research (HEOR) and Market Access projects while working in a fast-paced consultancy environment with a team of like-minded colleagues.

    Supporting colleagues with the writing of SOPs/WGs and templates as required
    Internally auditing and driving compliance with OPEN Health E&A policies and procedures by:
    Being an active member of the Quality Group (QG), organizing and running the QG meetings and documenting follow-up actions
    Managing the project issue escalation tracker
    Facilitating and supporting external quality and compliance activities:
    Supporting the Associate Director, Quality and Compliance by developing, implementing, and tracking Corrective and Preventative Actions (CAPAs) after audits

    Qualifying sub-contractors and third-party suppliers (TPS) according to the TPS Qualification


    SOP:
    Supporting the G&C and Learning & Development Teams to manage internal and external compliance training:
    Facilitating internal training (policies, SOPs, and WGs) and external (e.g., client-specific training, adverse event) for staff members and maintaining training records when required

    Collaborating with the Global Governance & Compliance Team on group-level data privacy and compliance-related initiatives:
    Cascading and implementing policies
    Driving the implementation and monitoring of the required documentation of data protection processes
    Supporting the OPEN Health E&A team in the event of any data breach reporting
    Conducting data privacy impact assessments (DPIAs) and Legitimate Interest Assessments (LIAs) for OPEN Health E&A projects
    Providing advice and support to colleagues in E&A business areas to help them meet quality and/or compliance-related objectives and responsibilities

    Reporting adverse events/serious adverse events according to client requirements and timelines, including reconciliation as appropriate
    Supporting other quality and/or compliance-related administration duties as required
    Keeping up to date on relevant quality standards, best practices, and regulatory requirements
    Assisting with providing internal quality and/or compliance-related training where necessary
    Attending regular internal team meetings to facilitate a collaborative approach to all projects
    Contributing to the continuing achievements and targets of OPEN Health E&A through the high-quality delivery of projects to agreed standards and timelines
    Maintaining quality and accuracy in all activities, following OPEN Health Policies and SOPs and ensuring compliance with data privacy regulations
    Supporting the Associate Director and CoE leads with problem solving and management decision making related to improved communication and solid decision management
    Overseeing project delivery and acting as a senior decision maker for project escalations with a focus on client satisfaction
    Demonstrated experience in a quality or compliance environment
    Experience of working within the healthcare or scientific research industry and a good understanding of the different regulatory requirements and research methodologies
    In-depth knowledge of quality systems ideally within the pharmaceutical industry
    Excellent written and verbal communication skills, fluent in English
    Experience of writing clear and unambiguous process documents
    Strong leadership skills and the ability to manage people and projects effectively
    Exemplary leadership ability, to effectively articulate quality related issues to all levels of personnel
    Proficient in MS365 including Word, Excel, Power Point, Outlook and Teams
    Experience working in SharePoint is preferred

    Travel Requirements
    5-10% potential global travel

    OPEN Health unites deep scientific knowledge with wide-ranging specialist expertise to unlock possibilities that improve health outcomes and patient wellbeing.

    OPEN Health is a flexible global organization that solves complex healthcare challenges across HEOR and market access, medical communications and creative omnichannel campaigns.

    Competitive pay, generous paid vacation and holidays, and health insurance programs across all our locations
    Ongoing training and development opportunities which foster and shape your individual career path
    An active and growing commitment to bettering the communities our employees call home through our Corporate Social Responsibility program
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