Product Quality Expert

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.

• 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 Track Wise.
• 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.

• 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 Track Wise, Veeva, and eCTD viewer.

Neuchâtel, Switzerland

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.

• 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.