Products Portfolio Quality Manager

Amsterdam, North Holland, Netherlands

Description

For our Quality team External Network we are currently recruiting a Product Portfolio Quality Manager. In this dynamic role you will be responsible for the Quality Governance over the portfolio of products and CMO's assigned. This role will be based in Rueil-Malmaison.


Responsibilities:
  • Ensure monitoring and review of partners quality perform
  • CMO compliance through review of activity and output from audits.
    • Identify and agree on improvement actions together with the partners
    • Create, negotiate and maintain Quality Agreements with partners.
    • Review, evaluate, and contribute to investigation into OOS or major deviations communicated by the partners and follow-up on corrective actions associated.
    • Assess any change control related to the products portfolio managed
    • Ensure change control request made by the partners are evaluated internally and follow-up on implementation plan when change owner
    • Review and evaluate answers to complaints received from our partners and follow-up on actions agreed.
    • Review and approve the product quality review provided by the partners
    • Prepare the product quality review when Norgine is responsible
    • Review and analyse the trend associated to stability results communicated by our partners
    • Review and approve protocol and validation report
    • Lead specific projects when required

  • Requirements




    Benefits

    Excellent renumeration package

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