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CMO/API/EUCAN Manager

Zurich, Switzerland, Dublin, Ireland

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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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

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

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • 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 2018.

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

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CMO/API/EUCAN Manager

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Job ID SR0044203 Date posted 11/21/2019 Location Zurich, Switzerland; Dublin, Ireland

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as our Supplier Quality Manager – CMO/API – EUCAN.

As our successful Supplier Quality Manager – CMO/API you will be responsible for managing the development, deployment and maintenance of Supplier Quality and Material Management programs.

You will be managing qualification, maintenance and monitoring for the supplier base in your region, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability 

You will partner with the business and other Quality leaders and key stakeholders to drive continuous improvement in Quality performance across the company to understand priorities and to align on expectations

You will be 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

Key Accountabilities

  • Managing of global 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
  • Managing Build and develop key leadership competencies within the team, including establishing a leadership talent pipeline and identifying development opportunities
  • Support the development and execution 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 maintenance of global audit and specification policies, guidance, standards, procedures governing Quality Auditing and Supplier Quality and ensures staff comply with the documents
  • Support 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
  • 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
  • Executes the Supplier Qualification and Product/Material Specification program requirements per schedule
  • Support KPIs activities and derive strategic decisions from the data related to the program improvement
  • Provides performance metrics to drive continuous improvement of the programs

Education, Behavioural Competencies  

  • Scientific degree (BSc, MSc)
  • 5+ years of increasing management responsibility combined with deep knowledge of biopharmaceutical manufacturing
  • Experience across all 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.
  • Excellent critical thinking, analytical, and problem solving skills
  • Current on local and global regulations
  • Strong communication skills engaging stakeholders: site, business, network, company, regulators.
  • Strong courage of conviction and conflict resolution skills.
  • Risk identification, evaluation and management
  • Continuous improvement
  • Ability to present key quality/department/business concepts to senior representatives of external business partners and internal senior leadership teams.
  • May require up to 50% travel

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 SR0044203

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