Product Quality Expert

Description

About the role:

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.

How you will contribute:

• 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 TrackWise 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

What you bring to Takeda:

• 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

What Takeda can offer you:

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 cafeteria, medical annual check-ups starting at age 50, financial support and preventive health care insurance
• support for preventive healthcare.
• Family Support: Paid leave for maternity, paternity, and adoption, along with dedicated spaces for nursing mothers.
• Career Development: Access to a Learning Catalog, language courses, and opportunities for internal and international mobility.
• Transportation & Eco-Benefits: Contributions for public transport, incentives for e-biking, and on-site charging stations for electric vehicles. Regular on-site gardening and massages activities.

Important Considerations:

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers that may require respiratory protection.

More About Us:

With over 650 employees, Takeda Neuchâtel is one of the ten largest employers in the Canton of Neuchâtel, and one of the leading biopharmaceutical production sites in Switzerland. Operating 24 hours a day, 7 days a week, the site employs a wide range of professionals trained in biotechnologies and their application to industrial production. With over twenty nationalities, Takeda Neuchâtel offers an international, diverse and innovative working environment within a company that is firmly rooted in and committed to its local ecosystem.

Takeda Neuchâtel is certified as a Training Company by the Swiss State Secretariat for Economic Affairs. We train young apprentices in a variety of fields, including laboratory quality control, logistics, IT and biopharmaceutical production.

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.

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Locations

CHE - Neuchatel

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time