Vendor Quality Lead

il y a 2 semaines

Brainel'Alleud, Belgique Randstad Travail à distance Freelance Temps plein

 We are looking for a Vendor Quality Lead for one of our clients based in Braine-lâAlleud.

This is a project contract as a Consultant (employee or freelancer): project starting asap until December 2024 with possible extension in 2025.Don't hesitate to contact me: delphine.vanriet@professionals.randstad.be




belangrijkste verantwoordelijkheden

As Vendor Quality Lead, your main tasks will be :

  • Be the central QA point of contact for the organization for investigations / deviations / out of-specifications / audit observations associated with the assigned vendors. Perform the QA  review of deviation notifications, retrieve and collect supportive information from involved  stakeholders (Vendor Team, GQL, ILA, ALO, Business) to allow assessment.  
  • Manage the key performance indicators (metrics) for key operational QA activities and  services associated with the vendors in the defined described tracking tools and track the  vendorâs performance 
  • Ensure all Quality agreements are in place and take ownership of agreements for the  vendors. Maintain Quality Agreement with the vendors up to date and perform periodic  reviews and update of the agreement in close collaboration with the vendors. 
  • When applicable, be sure that the Annual Product Stability Program is rolled-out and  executed at the vendor in accordance with our client'sStability Program 
  • Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely  manner and as needed and are reviewed within the requested time period. Ensure that this  review is documented and made available in the Controlled Documents System. 
  • Participate as QA representative to the recurrent vendor meetings, present issues and  resolutions, and drive vendor quality performance through these meetings (7) Quality Complaints: be the contact person for the follow-up with vendors for the  manufacturing investigation part. When applicable, ensure that initial receipt, logging of  quality complaints into the Complaint System and provision of responses to the  complainant are professionally coordinated and managed. 
  • If needed work with the Vendor team and Global Quality Lead to determine the Root cause  of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate  vendor quality related investigations 
  • Participate on ad-hoc basis to the Product Change Control Committees or product  complaint committee for activities related to the vendors 
  • Provide in-depth expert QA advice, support and management for technical operational  QA and general QA strategic matters associated with the vendors  



    jouw aanbod

    As Vendor Quality Lead,  we expect the following competencies :

    • Minimum of 5 years working in the pharmaceutical /biologics industry in a quality management position.
    • Operational GMP experience would be a distinct advantage.
    • Experience in interaction with regulatory bodies and third-party organizations with respect to QA systems and regulatory inspection preparedness.
    • GMP auditing experience is an advantage
    • Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has goodbackground knowledge of the pharmaceutical industry from a business and technical perspective.
    • Must be able to work independently and handle complex / difficult situations. Output from actions will most likely impact activities across several departments.
    • Possess good auditing capabilities and skills.
    • Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
    • Must have the ability to manage projects / activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.
    • Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
    • Generate commitment from within teams, encourage and support new ideas and act as a role model for others in driving the departmental / company vision.
    • Must be skilled and experienced in operating across cultures and in a multi-cultural environment.
    • Root cause and risk management/assessment skills.

      ons aanbod

      For the position of Vendor Quality Lead, we offer an attractive salary with extra-legal advantages : 

      • Group insurance
      • Hospitalisation insurance
      • Meal vouchers of 7 euros gross per working day
      • Reimbursement km or company car 
      • Monthly allowance (80 euros net per month)
      • A 13th month
      • Training
      • Etc

        A rate as freelance is also possible

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