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Brentford

    Quality Manager and Regulatory Affairs - Brentford, Greater London, United Kingdom - GlaxoSmithKline

    GlaxoSmithKline
    GlaxoSmithKline Brentford, Greater London, United Kingdom

    2 weeks ago

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    Description

    We're excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024.

    At GSK HQ, we're building an energising space where we can connect, collaborate and get ahead of disease together.

    Designed especially for us, it'll be one of the healthiest workplaces in the world, with best-in-class tech and bright, light spaces to help us thrive.

    Head of Quality, ViiV Healthcare

    ViiV Healthcare is a global specialty HIV company, the only company that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV.

    ViiV has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. As our Head of Quality, you will Provide quality leadership in support of all aspects of the ViiV business.

    This includes working with ViiV Central functions and Local Operating Companies, GSK R&D, GSK Supply Chain, Pfizer, Shionogi and third party business partners and suppliers.

    To ensure that ViiV, as a Manufacturing Authorisation holder (MAH), has a comprehensively designed and correctly implemented quality system incorporating good manufacturing practice, good distribution practice and quality risk management.

    To ensure that the ViiV Leadership continue to support the quality system and ensure the commitment of staff at all levels and all locations within the organisation.

    To ensure that all suppliers, including GSK/GSC as ViiV's major supplier, follow their own product quality systems. This would include oversight of factory compliance and quality performance to adequately protect ViiV's commercial and compliance business risks.

    To work as part of the GSK's GSC Quality Organisation to ensure there is independence of decision making and to ensure that all activities subcontracted to GSK under the Support Services Agreement are implemented efficiently and effectively.

    To work as part of the GSK's GSC Quality organisation to ensure that ViiV has access to the necessary Quality resources with necessary competencies to fulfil its quality responsibilities as an MAH.

    To work as part of the GSK's GSC Quality organisation to influence and discuss quality strategies that could, as GSK is the major supplier, impact the ViiV supply chain.

    To ensure that risks that could affect the quality for the products for which ViiV are the MAH are adequately managed.

    To be the ViiV Quality representative on the appropriate governance boards throughout the lifecycle of products (R&D, manufacturing and supply)
    To chair ViiV quality governance boards (ViiV Quality Council).
    To be the Quality representative on the ViiV Recall Board
    Fulfil all responsibilities as Responsible Person in the worldwide virtual wholesale distribution operations of ViiV Healthcare Trading Services UK Limited
    Degree in a relevant scientific discipline (e.g. Chemistry, Biology or Pharmacy) and significant relevant experience in senior Quality positions

    A broad based technical knowledge of critical aspects of manufacturing, quality and regulatory activities and requirements associated with production and distribution of pharmaceuticals.

    In depth understanding of Quality and cGMP/cGDP applicable within the pharmaceutical industry, developed though demonstrated experience in Operational Quality
    Complementary experience in manufacturing management roles highly desirable
    PhD

    Inspirational leadership, managerial development experience skills to lead and motivate a diverse, high-performance team of internal and external Business Partners/Providers and Regulatory organisations.

    Please apply via our online portal providing your CV and Cover Letter.
    (Please take a personal copy of the Job Description, as this will not be available online post closure of the advert)
    Hybrid working applies to this role, with ViiV expectation of minimum 2 days per week being office based.

    We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

    our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

    At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently.

    Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic.

    We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care.

    Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities.

    All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

    All employment businesses/agencies are required to contact ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment.

    This capture of applicable transfers of value is necessary to ensure ViiV's compliance to all federal and state US Transparency requirements.

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