Product Quality Expert

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As a Quality Product Expert, you will be responsible for one biological product manufactured on site and act as an expert for all the topics related to regulatory compliance for this product; support colleagues with other products when necessary. You will act as a “Subject Matter Expert” in the creation and modification of regulatory license sections for products manufactured in Neuchâtel (clinical phase III and commercial), for which the job holder is responsible.

• Prepare Product Quality Reviews (PQR) for products manufactured at the Neuchâtel facility, annually and according to health authority requirements;
• Review global release specifications, ensuring the implementation of correct updated versions for products manufactured at Neuchâtel facility, when applicable;
• Participate in GMP tours of facility to ensure inspection ready status.
• Manage/prepare the necessary supportive documentation for regulatory submissions and for major change projects in Neuchâtel facility;
• Prepare/Review documentation for change controls, audit observations and regulatory agency questions;
• Support/Write the responses to regulatory agency questions, and if necessary, facilitate the collaboration among several Subject Matter Experts to achieve the required documentation.
• Supports the preparation of the inspections
• Supports the preparation of pre-required documents
• Participates in audits and inspections as required (ACC room or inspection room)
• As part of the quality matrix team, helps to define of the strategy of responses to health authority questions; assists in the preparation and implementation of corrective and preventive actions
• Updates all records relative to the inspection in Track Wise when necessary
• Proposes improvement initiatives to simplify and streamline the tasks described above.
• Assist in preparation and review of all quality documentation as required
• Participate in Quality Council meetings as necessary
• Support the coordination of site Key Performance Indicators (KPIs)
• Participate in project teams when necessary (depending on expertise and project focus)
• Participate in product launch activities
• Identify opportunities to improve quality processes
• Collaborate with the global Quality Product Leads and Regulatory Affairs partners

• University degree in technical/ scientific discipline such as biochemistry, chemistry, engineering or equivalent
• At least 3-5 years of experience with manufacturing in the biotechnology and/or pharmaceutical industry, preferably both
• Experience in writing and/or reviewing eCTD licenses (quality - module
  3)
• Experience with the regulatory affairs framework (CMC).
• Good knowledge of FDA, EMA, ICH regulations and quality system standards
• Experience as a change owner or project leader
• Knowledgeable in GMP inspections and management of regulatory / quality standards.
• Fluent in English & French
• Knowledge/Experience with quality tools such as Trackwise 8, Veeva, eCTD viewer
• Good knowledge of FDA, EMA, ICH regulations and quality system standards
• Experience as a Change owner or project leader
• Knowledgeable in GMP inspections and management of regulatory / quality standards

We want our employees to succeed in everything they do – at work, at home, and in the community. This is why we offer world-class benefits and access to resources that can support people.

Our sector and the needs of our patients are constantly changing, which is why we emphasize continuous training. We actively support and invest in the development of our employees through a 50/40/10 training model.

We offer a comprehensive benefits package, prioritizing wellbeing, career growth, and work-life balance:

• Generous Time Off: 28 days of paid.
• Health & Wellbeing:
  Sport/Fitness abonnement contribution, on site…