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Head of Quality Systems

Neuchâtel, Switzerland

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Head of Quality Systems

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Job ID SR0045049 Date posted 12/19/2019 Location Neuchâtel, Switzerland

Takeda Neuchâtel

Site de Production Biotech | Biotech Manufacturing Site

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

An exciting and challenging opportunity has become available at Takeda’s Neuchatel Manufacturing plant (approx. 650 employees) for an experienced…

Head Quality Management Systems

…to join our Quality leadership  team.

Job Summary

As “Head Quality Management Systems”, you will have the overall responsibility to ensure that the Quality System processes are effectively established and maintained, as well as improve overall site capability. This includes oversight and sustainability of the Global Quality Management System as well as adherence to supplemental local regulatory requirements. Additionally, Head of Quality Systems manage through subordinates the coordination of the activities of several functions within the Quality organization including the Deviation/CAPA and Change Control quality systems, and Validation Quality Management.

Reporting into our local Site Quality Head, you will be a member of the Site Quality Leadership Team and will partner closely with other peers from the Takeda network, to leverage lessons learns.

In this role, you will also be providing leadership to a quality professional team supporting talent growth as well as linking the people process with a quality systems business strategy for the site.

Main accountabilities

  • Establishes goals for the Quality Systems department in alignment with the global and site strategy, and takes action as needed to ensure timely delivery of goals.
  • Responsible for ensuring compliance with all applicable provisions of the Takeda Quality Management System, and the regulations and standards applicable to Neuchâtel operations.
  • Conducts gap analyses and implements Quality Management System procedures in several departments and manages compliance.
  • Understands and assures conformance to applicable regulations. Interfaces with regulators during inspections in the roles of escort and SME concerning Deviation/CAPA and Change Control quality systems.
  • Responsible for Validation Quality and the oversight of the site Validation Master Plan and Engineering Validation activities.
  • Responsible of the quality documentation management and site quality metrics
  • Responsible to develop the GMP training for the site
  • Manage quality aspects for local suppliers (quality agreements, complaints, quality metrics)
  • Seeks new ways to improve and streamline current business and system processes. Identifies, manages, and where appropriate, leads multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements.
  • Owns and approves Deviation/CAPA investigations related to Neuchâtel operations.
  • Responsible for the coaching, training, and development of the Quality Systems team.
  • Develops budget for department and ensures adherence to the budget.

Qualifications

  • Bachelor’s – Master’s degree in Life Science, pharmacy, chemistry, biology or a related discipline.
  • Profound experience in Quality or related field in the pharmaceutical industry.
  • At least 5 years of leadership experience, developing people and strength in managing projects and initiatives
  • Fluent English and French
  • A thorough understanding of pharmaceutical quality management systems relating to clinical and commercial manufacturing, including current GMPs & GDPs.
  • Must have proficiencies with the Quality systems and, preferably, with business processes associated with automation and integration of testing and production systems.
  • Demonstrated ability to work autonomously and to lead project teams in a matrix organization.
  • Organizational and ability to apply that capability to lead change, deliver strong results and build the confidence as well as trust of stakeholders.
  • Experience with Continuous Improvement initiatives
  • Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
  • Strong presentation and organizational skills
  • Candidates with experience in drug substance (or API) and drug product are preferred.
  • Experience/expertise with TrackWise Deviation/CAPA, Change Control Management (CCM), and Electronic Batch Management (EBM) systems preferred.
  • Must be well versed in validation disciplines. Must possess knowledge of related disciplines.

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 SR0045049

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