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QI Investigation Management Lead

Dublin, Ireland, Zug, Switzerland

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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QI Investigation Management Lead

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Job ID SR0039469 Date posted 08/13/2019 Location Dublin, Ireland; Zug, Switzerland

Join us as a QI Investigation Management Lead in our offices in either Dublin, Ireland or Zurich - Opfikon, Switzerland.

OVERVIEW

  • The QI Investigation Management Lead is accountable for leading significant site/regional investigations, driving to determine root cause, product impact, CAPA and timely investigation closure.
  • The QI Investigation Management Lead supports the development of increased investigation capabilities across sites/regions network.
  • The QI Investigation Management Lead is accountable for determination of product impact for significant events and triggering the incident escalation process in a timely manner when required:
  • The QI Investigation Management Lead ensures effective investigation management for significant Quality Incidents which will potentially trigger the Takeda incident management process.
  • The QI Investigation Management Lead interacts with a broad range of internal stakeholders to ensure complex events/investigation are efficiently managed, escalated if required and progressed to closure in a timely manner.
  • The QI Investigation Management Lead develops and rolls out investigation training to build sustainable investigation capabilities across the Takeda site/regions.

ACCOUNTABILITIES

The key accountabilities of the QI Investigation Management Lead include, but are not limited to:

  • Accountable for driving significant site/regional investigation to root cause, determination of product impact, scope definition, can CAPA effectiveness.
  • Accountable for developing and delivering a comprehensive training program to build sustainable cross functional investigation capabilities across sites/regions.
  • Accountable for timely triggering of the incident escalation process for significant investigations which have potential product quality/patient safety impact.
  • Accountable for representing the Takeda investigation process during site regulatory inspection.  
  • Responsible for leading/support site remediation where significant compliance deficiencies are identified.
  • Responsible for the execution of site complaint investigation in a timely manner (as needed).

DIMENSIONS & ASPECTS

Technical/Functional (Line) Expertise

  • Knowledge and understanding of Biologics, Plasma and Small Molecule manufacturing therapeutic areas as well as scientific advances and modalities for treating diseases.
  • Deep knowledge and understanding of international heath authorities’ compliance requirements

Leadership

  • Ability to lead significant investigations related to Quality Incidents, drive to root cause, product impact, CAPA and timely investigation closure.
  • Ability to lead and engage in complex investigations and propose sound, scientific and compliant resolutions and ensure escalation to the incident management process as required.
  • Ability to support increased organizational investigational capability across sites, regions and OpUs as required.  

Decision-making and Autonomy

  • A member of the PQ & IM team – contributing to the execution of strategic plans for the function and development of annual goals.
  • Responsible for supporting the increased investigation capabilities across sites/regions and OpUs.

Interaction

  • Key interactions across all manufacturing and Quality regional and operating unit teams
  • Key interactions with Supply & Business Excellence to support increased investigation capabilities across the sites/regions/OpU.
  • Key Interactions with the OpU and Region Compliance Leads.
  • Key interactions with the incident management team to ensure timely escalation of significant events/incident and regulatory reporting if required.

Innovation

  • A firm grasp of industry, scientific and regulatory trends, understands market conditions, and leverages innovation to evolve Takeda’s profile to become the model for the industry.

Complexity

  • This is a global role with significant impact on Takeda’s ability to investigate significant and complex manufacturing events and to facilitate timely escalation and decision making. The output from this role and the associated team is applied across the Takeda product portfolio. 

EDUCATION, BEHAVIOURAL COMPETENCIES & REQUIRED SKILLS

Education & Experience

  • Scientific degree (BSc, MSc)
  • 10+ years of experience in the pharmaceutical industry working within the Quality organization
  • Experience working in an international environment
  • Knowledge and experience of Bio-Pharmaceutical Manufacturing and the management of complex investigations
  • Deep knowledge and understanding of international heath authorities’ compliance requirements
  • Fluent in written and spoken English

Core Competencies & Skills

  • Critical Thinking
  • Current on local and global regulations
  • Digital and analytical skills
  • Problem solving, fishbone, DMAIC
  • Strong communication skills engaging stakeholders: site, business, network, company, regulators
  • Risk identification, evaluation and management
  • Continuous improvement

Leadership Behaviors

  • Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
  • Creating the environment that inspires and enables people
  • Focusing on the few priorities and provide superior results
  • Elevating site/regional/OpU investigation capabilities for now and the future

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com

What Takeda Can Offer You

To further support and inspire our employees, our benefits include: Competitive basic salary, Annual Bonus, Long Term Incentive Plan, Contributory Pension Scheme, Private Health Cover and Life Assurance.

Empowering Our People to Shine

Learn more at takedajobs.com

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 SR0039469

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