Product Quality Expert
Takeda is looking for a Product Quality Expert to manage regulatory compliance for a biological product manufactured at our Neuchâtel facility in Switzerland. You will serve as a subject‑matter expert, supporting other products when needed, and ensuring adherence to FDA, EMA, ICH, and other regulatory standards.
Responsibilities
* Prepare annual Product Quality Reviews (PQR) in accordance with health authority requirements.
* Review and implement updated global release specifications for the Neuchâtel facility.
* Participate in GMP tours and inspections, ensuring the facility is inspection‑ready.
* Prepare and manage documentation for regulatory submissions, major change projects, and change controls.
* Review audit observations and regulatory agency questions, writing responses and coordinating with SMEs.
* Support the preparation of inspection and pre‑required documents.
* Participate in audits/ inspections (ACC or inspection rooms) as required.
* Assist in defining the strategy for responding to health‑authority questions and in implementing corrective and preventive actions.
* Update inspection‑related records in TrackWise.
* Propose improvement initiatives to simplify and streamline quality processes.
* Prepare and review quality documentation and attend Quality Council meetings.
* Coordinate site KPIs and participate in project teams and product launch activities.
* Identify opportunities to improve quality processes and collaborate with global Quality Product Leads and Regulatory Affairs partners.
Qualifications
* University degree in a technical/ scientific discipline (e.g., biochemistry, chemistry, engineering).
* 3–5 years’ experience in biotechnology and/or pharmaceutical manufacturing.
* Experience writing and reviewing eCTD licences (module 3).
* Knowledge of the regulatory framework (CMC) and of FDA, EMA, ICH regulations.
* Experience as a change owner or project leader.
* Knowledge of GMP inspections and quality‑system standards.
* Fluency in English and French.
* Familiarity with quality tools such as TrackWise, Veeva, and eCTD viewer.
Location
Neuchâtel, Switzerland
What Takeda Can Offer You
We provide a comprehensive benefits package and a work‑life balance focused culture, including:
* 28 days of paid time off.
* Health and wellbeing programmes, on‑site cafeteria, and medical check‑ups.
* Family support: paid maternity, paternity, and adoption leave.
* Career development via a learning catalog, language courses, and international mobility.
* Transportation and eco‑benefits for public transport, e‑biking, and electric vehicles.
Important Considerations
* Work in a controlled environment with respiratory and hearing protection, gowning, and protective clothing.
* Make‑up, jewelry, contact lenses, nail polish, and artificial nails must be removed from the manufacturing area.
* Shift work, including weekends and supplemental hours, may be required.
* Exposure to chemicals such as alcohol, acids, and buffers may require respiratory protection.
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