ジョブNo.534961 Supplier Quality Management(Associate Director or Manager)

  • 正社員
  • 上場企業
  • 従業員1000名以上
  • 年間休日120日以上
  • 女性が活躍
  • フレックスタイム

非公開

【OBJECTIVES/PURPOSE】
・Managing the development, deployment and maintenance of Supplier Quality and Material Management programs
・Managing qualification, maintenance and monitoring for the supplier base in her/his region, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability
・Partners with the business and other Quality leaders and key stakeholders to drive continuous improvement in Quality performance across the company, to understand priorities, align on expectations
・Supporting global cross functional stakeholders 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】
・Managing of gloabel supplier and material/product management and audit activities within assigned category and geographical regions including:
 -Building relationships with global / critical / key suppliers
 -Development and maintenance of product / material specifications
 -Solving of material related issues in cooperation with impacted facilities and suppliers resp. manufacturers around the globe (Material Deviations, CAPAs)
 -Supplier Qualification and maintenance / Quality Agreements
 -Supplier Audits
 -Evaluation and Excecution of Notification of Changes
 -Managing change controls e.g. due to product/material specification changes
 -Supplier Monitoring
・Support the Design and implement a unified and shared audit services platform throughout Takeda to enable consistent and effective internal and external audit operations and Due Diligence audit support activities worldwide
・Support the maintainance of an environment of teamwork and collaboration
・Managing build and develop key leadership competencies within the team, including establishing a leadership talent pipeline and identifying development opportunities
・Support the development and execute of strategic direction and oversight pertaining to external auditing and supplier quality and material management achieves sustained success for regulatory inspections and supply chain product quality
・Support the preparation and the maintainence of global audit and specification policies, guidance, standards, procedures governing Quality Auditing and Supplier Quality and ensures staff comply with the documents
・Managng the coordination with Site QA auditors, Supplier Quality management groups and global audit planning / scheduling group to assign lead auditors and co-auditors within region to perform audits according to annual (fiscal year) audit plan
・Promptly escalate and report all critical audit findings, critical material issues and supplier performance incidents to the appropriate persons
・Perform internal/external audits as needed (aprox. 30 % travel due to audits)
・Support Due Dilignece activities wordwide providing subject matter expertise to enable decision making; identifying quality related risks to projects and the provision of appropriate resolutions
・Executes the Supplier Qualification and Product/Material Specification program requirements per schedule. Deliver input for provess optimazation.
・Managing and support KPIs activites and derive strategic decisions from the data related to the program improvement
・Provides performance metrics to drive continuous improvement of the programs

コンサルタント 柴田 理

募集要項

職種 購買・物流・貿易系/SCM企画・物流企画・需要予測、メディカル系/医薬品質保証(QA)(本社)
年収 700万円~1400万円
勤務地 大阪府
応募資格 【EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS】
・Scientific degree (BSc, MSc)
・5+ years of increasing management responsibility combined with deep knowledge of biopharmceutical manufacturing
・Experience across all of the Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) including global cGMP regulations (US, EU, Japan, Canada, etc.) and working in an international environment
・Experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections highly desirable/preferred.
・Fluent in written and spoken English
・Good technical report writing
学歴
雇用形態 正社員(期間の定めなし)
勤務時間 8:00〜16:45
本社(大阪・東京) 9:00~17:30
工場(大阪・山口) 8:00~16:45
研究所(神奈川)9:00~17:45
休日・休暇土、日、祝日
年間休日 123日
年末年始休暇、育児休暇、介護休暇、GW休暇、慶弔休暇
メーデー、特別有給休暇、リフレッシュ休暇、産前産後休暇、子の看護休暇、フィランソロピー休職制度 働き⽅関連制度:フレックスタイム制、テレワーク勤務制導⼊(対象社員)
待遇・福利厚生社宅、従業員持株制度、財形貯蓄
住宅融資、企業年金制度、借家補助費
健康保険、厚生年金、労災、雇用保険
通勤交通費(全額)、残業代(一部)、住宅手当

企業情報

企業名非公開
業種・資本 メーカー系(医薬品・医療機器(メーカー))
ヘッドオフィス:国内

Supplier Quality Management(Associate Director or Manager)

  • 購買・物流・貿易系/SCM企画・物流企画・需要予測、メディカル系/医薬品質保証(QA)(本社)
  • 700万円~1400万円
  • 大阪府