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Quality Supplier

応募後で応募 求人ID R0064822 掲載日 04/14/2022 Location:Lessines, Belgium

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Job Description

About the role

  • 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 local 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

How you will contribute:

  • 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/manufacturers around the globe (Material Deviations, CAPAs)
    - Supplier Qualification and maintenance / Quality Agreements
    - Supplier Audits / Supplier Questionnaires
    - 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 worldwide 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

What you bring to Takeda

  • Scientific degree (Bachelor or Master)
  • 1-2+ years of responsibility combined with deep knowledge of biopharmaceutical 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, technical writing 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

More about us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics, marital or other status. At Takeda, we embrace diversity as a whole.

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Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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