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  • Posted: Mar 24, 2021
    Deadline: Not specified
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    We are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of pharmaceuticals, vaccines and consumer healthcare. As one of the few healthcare companies researching both medicines and vaccines for the World Health Organization’s three priority diseases – HIV/AIDS, tube...
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    Quality, Capability & Risk Manager at GSK

    Job Purpose

    Hiring

    • The changes proposed under Future Ready are to integrate the Rx and Vx organisations and are driven by a belief that working together to drive a common approach to all GSK R&D will ultimately help us create better, more productive R&D for patients, by being more effective in how we allocate our budget, share technical expertise and deliver our pipeline. It includes the creation of a world class OneDevelopment organisation which will deliver one, consistent world-leading development support for GSK’s pipeline. Global Clinical Operations is integral to the success of the OneDevelopment organisation.
    • Global Clinical Operations is transforming to fulfil our vision to “Be the best performing and trusted Global Clinical Operations organization”. Our mission is to “Accelerate the pipeline through innovative, efficient and expeditious delivery of high-quality data”.
    • To work with the Director Regional Risk Management & Management Monitoring to ensure that Clinical Research activities are conducted by Regional Clinical Operations Staff in accordance to ICH GCP, relevant international and local regulations, requirements and guidelines, as well as GSK written standards.
    • To work across Regional Teams to share best practices and collaborate with other Managers on ways of working.

    Key Responsibilities

    • Assesses potential regulatory compliance issues and risks in clinical research activities conducted by Regional Clinical Operations Staff and to ensure these risks are properly managed, documented and escalated as appropriate within GSK.
    • Ensures that Regional Clinical Operations Staff are appropriately trained to effectively conduct clinical research activities and receive ongoing training to meet the changing regulatory environment and updates to GSK written standards.
    • Active contributor to the Global Quality and Training Network, taking on a leadership role for specific training and quality activities as part of the network. Also a member of any local quality teams.
    • Maintains an external focus, vigilance and networks to identify emerging trends in quality and compliance which impact the GICCO business area.
    • May Mentor and train colleagues throughout the Regions and act as the SME for the teams.
    • Responsible for all Clinical Operational quality issues locally and ensuring Clinical Research activities are conducted according to ICH GCP, local legislation and GSK written standards.
    • Responsible for the development and maintenance of local Risk Register, Quality Plan and delivering all aspects of business management monitoring activities in partnership with the business.
    • Responsible to implement ongoing quality improvement processes, maintain local written standards and support all assessments and inspections.
    • Accountable to design (when required), develop (when required) and deliver training identified globally and at a local level to support clinical operations processes and GSK written standards.
    • Identify and address any additional local training needs.
    • Mentor team staff across the regional teams.

    Other Skills

    • Excellent understanding of clinical research and the drug development process.
    • Can work both independently on projects and also part of a team.
    • Creative, logical, strategic thinker
    • Effective problem solver and conflict resolution
    • Good eye for detail and high learning agility
    • Excellent knowledge of ICH GCP / IND guidelines
    • Excellent knowledge of global and local GSK written standards.
    • Sound understanding of the Internal Control Framework
    • Able and willing to travel as required for the role.
    • Act as a role model in line with GSK values and behaviors
    • Collaborative and open Leadership style

    Knowledge/Education Required

    • Minimum Level of Education Required
    • Scientific Degree or equivalent experience ideally with some quality experience

    Area of Specialization

    • Any science degree e.g. life sciences, medicine, clinical research, pharmacy etc.

    Basic Qualifications/Experience

    • 5 years experience in Clinical Operations. Advanced knowledge of the drug development processes and key operational interfaces
    • High degree of organizational awareness; good understanding of clinical/corporate governance principles and demonstrated ability to develop solutions to complex problems with regard to quality and governance.
    • Ideally have previous experience in quality management, knowledge of GSK written standards and experience in delivering clinical research training.
    • Extensive knowledge of ICH GCP requirements with strong knowledge of local and global regulatory requirements applying to Clinical Trials.
    • Proven negotiation skills
    • Good written and verbal communication skills in English.
    • Fluent in local language if required.
    • Advanced user of MS Office (PowerPoint, Excel, Word & Outlook)

    Preferred Level Of Education

    • Master of Science or equivalent. Advanced degree preferred but not essential

    Area of Specialization

    • Any science degree e.g. life sciences, medicine, clinical research, pharmacy etc.

    Method of Application

    Interested and qualified? Go to GlaxoSmithKline (GSK) on jobs.gsk.com to apply

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