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    quality risk management coordinator - Mississauga, ON, Canada - GlaxoSmithKline

    GlaxoSmithKline
    GlaxoSmithKline Mississauga, ON, Canada

    2 weeks ago

    Default job background
    InternshipSHIP
    Description

    Site Name:
    Mississauga Milverton Drive
    Only candidates currently living in Canada, with the legal right to work her, will be considered.

    Reporting to the Quality Director, this position is responsible for leading Quality activities associated with Canada Market Supply of prescription products.

    Do you have what it takes to make key decisions associated with Quality processes and Quality incidences in the Canadian Market?Do you excel at being responsible for developing, leading, and coaching a team of technical/quality support staff?This function is critical to the effective management of systems and activities that are crucial or have a direct impact to product quality and regulatory compliance in the Canadian Market.

    This position must take the lead in implementing the QMS across the LOC and also include partnering with the commercial teams to embed and sustain quality processes in their day-to-day work.

    Provides leadership to the Quality LOC Canada Rx team.
    Acts as the deputy to the Quality Director LOC Canada in their absence.
    Provides effective and efficient quality assurance systems support to the Quality Director LOC Canada (Canada Rx and ViiV)
    Responsible for people management and supporting development of 3-5 quality professionals.
    Responsible for setting performance objectives and managing performance of direct reports.
    Leads Local Incident Committee meetings as required and manages related communications and actions with LOC business partners.

    Supports the implementation and maintenance of the QMS (Quality Management System) in Canada LOC (Rx) and ensures that Local SOPs are compliant with QMS and local regulations.

    Host Regulatory and/or 3rd party customer audits
    Supports the Quality Director LOC in the management of Quality Council
    Oversee the local audit program and define the audit universe for LOC Canada Rx
    Oversees quality activities for Canada Rx including Risk Management, and Quality Agreements
    Provide Quality oversight /leadership for local investigations, improvement projects, new business opportunities.
    May oversee batch release, complaints, Annual product reviews, deviations, change control.
    Ensures training program for quality is in place and effective.
    Quality oversight of 3rd party service providers in Canada including outsourced Canadian Distribution centres.
    Bachelor of Science or Engineering degree or equivalent
    ~ Minimum 8 years of pharmaceutical quality and/or compliance experience
    ~ Comprehensive knowledge of QA systems, manufacturing and testing processes and related regulatory requirements (cGMPs)
    ~ Demonstrated risk-based decision-making skills.
    ~ Demonstrated proficiency in computer systems.
    ~ Thorough technical and regulatory knowledge of current pharmaceutical manufacturing techniques and the applicable current regulatory and GSK requirements.
    ~ Ability to work alone and in cross functional teams.
    ~"Additional qualification in a scientific field (MSC or PhD)
    Experience in Project Management
    Strong Chemistry/ Manufacturing regulatory content understanding (CMC)
    Expertise in multiple computer systems, such as SAP and/ or Veeva

    We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

    GSK is an equal opportunity employer committed to diversity and inclusion.
    GSK is committed to accommodating persons with disabilities.

    If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada- .Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.

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

    GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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