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Head of Quality Services and Improvement (QSI)

応募後で応募 求人ID R0067453 掲載日 05/17/2022 Location:Dublin, Ireland

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Job Description

Head of Quality Services and Improvement (QSI)

About the role:

  • As the Quality Services and Improvement Lead (QSI), you will be an important member of the Quality Leadership Team for the External Biologics site, reporting directly to the Site Quality Head.
  • The external biologics operations of the Biologics Operating Unit incorporates activity at contract manufacturing and testing sites globally.
  • In particular, you will define the strategic direction of the Quality Department, particularly focusing on Continuous Improvement (Agile) and Quality Culture activities.
  • You will work with QA leaders in Takeda and external sites to influence and affect operations managed by the external biologics team across the external manufacturing and testing sites and for driving operational efficiencies.
  • You will collaborate closely with other external biologics quality leaders, including Quality Disposition, Quality Systems and Compliance, CMO Quality Oversight, Quality Control, and with External Operations and the QSI community in Takeda.

How you will contribute:

Incorporate integrity, fairness, honesty and perseverance into all work activities.

The responsibilities of the Quality Services and Improvement Lead include:

  • Define and monitor strategic goals for the Quality function following site and Global Quality objectives.
  • Develops, executes and reports performance metrics for the external biologics site, according to Takeda's operating model, that integrates Continuous Improvement and supports Takeda's oversight of compliance and performance.
  • Lead change and continuous improvement for the function and site.
  • Manage and promote the site's Agile program.
  • Define and lead innovation projects within Quality and participate in site innovation projects, especially digital projects.
  • Lead the site's Quality Culture program and embed a culture of quality throughout the site.
  • Define and monitor the Quality budget (Operational).
  • Plan and monitor resource requirements within Quality.
  • Implement and monitor Key Performance Indicators within Quality that are in consideration of quality objectives and that improve process performance.
  • Effectively promote and communicate Quality Improvement activities to the External Biologics site and the Takeda Global organization.
  • Mentor quality personnel.
  • Lead challenging investigations through established principles of Lean Six sigma (e.g. DMAIC).
  • Assume responsibilities in any work area of the External Biologics Quality Department, accordingly to the business needs.

In partnership with other members of the organization:

  • Provide support to External Operations area regarding routine operations.

What you bring to Takeda:

  • Primary Degree in a scientific discipline.
  • Green Belt training is desirable and Black belt training is an advantage.

Other Essential Requirements:

  • Minimum of 8 years' experience in the pharmaceutical industry
  • Minimum of 4 years' experience in a Continuous Improvement / Agile role with expertise in this area
  • Experience in parenteral biological manufacturing, particularly in the requirements for manufacture of sterile medicinal products (EU GMP Volume 4, Annex 1) and/or manufacture of biological active substances and products (EU GMP Volume 4, Annex 2).
  • Experience with collaborative working with Contract Manufacturing Organisations (CMO).
  • Technical report writing and reviewing.
  • Experience with product supply chain architecture.
  • Excellent knowledge of cGMP
  • Lean / 6 sigma / AGILE experience
  • Fluent in English.
  • Proficient in technical report writing and assessment.

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 status, or any other characteristic protected by law.


IRL - Dublin - Baggot Street

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