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Supplier Quality Management Professional

Lessines, Belgium

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Supplier Quality Management Professional

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Job ID SR0048016 Date posted 03/25/2020 Location Lessines, Belgium

Supplier Quality Management Professional

Objectives/Purposes

  • Driving the development, deployment, execution and maintenance of the Supplier Quality and Material Management programs at the Lessines plant
  • Execution of qualification, maintenance and monitoring for the plant’s suppliers, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability 
  • Partners with the business and key stakeholders to drive continuous improvement in Quality performance across the plant and the company, to understand priorities, align on expectations
  • Supporting local cross functional stakeholders and stakeholders in the Plasma OpU on matters pertaining to supplier controls, significant concerns related to Quality System performance, risk-based audit execution, issue escalation, procurement strategy and regulatory compliance

Accountabilities

  • Execution of global supplier and material/product management and audit activities for the suppliers assigned to the Lessines plant:
    • Building relationships with the locally assigned suppliers
    • Creation and maintenance of local product / material specifications
    • Solving of material related issues in cooperation with impacted production departments or Quality Control and suppliers resp. manufacturers around the globe (Material Deviations, CAPAs)
    • Supplier Qualification and maintenance / Quality Agreements
    • Supplier Audits
    • Evaluation and Execution of Supplier Notification of Changes
    • Managing change controls e.g. due to necessary product/material specification changes
    • Supplier Monitoring
  • Contribute to a teamwork and collaboration environment
  • Execute the strategic direction and oversight pertaining to external auditing and supplier quality and material management to achieve sustained success for regulatory inspections and supply chain product quality
  • Ensure compliance with the global audit and specification policies, guidance, standards, procedures governing Quality Auditing and Supplier Quality
  • Plan audits according to annual (fiscal year) audit plan
  • Support the coordination with Global Supplier Quality management group and global audit planning / scheduling group to assign lead auditors and co-auditors to perform audits for critical local suppliers
  • Promptly escalate and report all critical audit findings, critical material issues and supplier performance incidents to the appropriate persons
  • Perform external audits as needed (up to 15 % travel time due to audits)
  • Support Due Diligence activities wordwide providing subject matter expertise to enable decision making; identifying quality related risks to projects and the provision of appropriate resolutions
  • Execute the Supplier Qualification and Product/Material Specification program requirements per schedule
  • Provide performance metrics to drive continuous improvement of the programs

Education, competencies and skills :

  • Scientific degree (Bachelor or Master)
  • 1-2+ years of responsibility combined with deep knowledge of biopharmceutical manufacturing
  • Experience about Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) including global cGMP regulations (US, EU, Japan, Canada, etc.)
  • Understanding of local and global regulations.  Experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections preferred.
  • Fluent in written and spoken French and English
  • Communication skills engaging stakeholders: site, business, network, company, regulators.
  • Personal accountability for results and integrity.  Critical thinking, analytical, and problem solving skills.  Ability to drive change
  • Ability to present key quality/department/business concepts to senior representatives of external business partners and internal senior leadership teams.
  • Strong PC skills and be competent in Word, Excel, PowerPoint and SharePoint

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.



Job ID SR0048016

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