Supplier Quality Management Professional
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Supplier Quality Management Professional
- 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
- 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