Specialist Quality Operations

About the role

The Specialist Quality Operations will oversee quality for the manufacturing of monoclonal antibodies at Incyte’s large‑scale bioplant in Yverdon‑les‑Bains, Switzerland. The role ensures compliance with cGMP, supports on‑time product supply and drives continuous improvement across all manufacturing departments.

Key responsibilities

• Manage day‑to‑day quality oversight of USP and DSP manufacturing, washing area and media/buffer preparation, including floor presence in classified areas.
• Perform batch record reviews within defined timelines and recommend disposition.
• Review and approve SOPs, Master Batch Records, deviations, investigations and CAPA plans.
• Ensure compliance with cGMP, regulatory requirements and Incyte policies for documentation, materials traceability and change control.
• Conduct GMP tours/Gemba, track actions and represent QA in routine operational meetings.
• Collaborate closely with manufacturing to anticipate issues, promote right‑first‑time operations and foster a strong quality culture.

Required profile

• Academic degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering).
• Minimum 3 years experience in Quality Operations at pharmaceutical manufacturing sites.
• Fluent in written and spoken French; good level of English.
• Strong analytical and problem‑solving abilities, compliance‑focused mindset.

Required skills

• cGMP and GMP knowledge.
• Batch record review and SOP management.
• CAPA development and implementation.
• Regulatory and quality system interpretation.
• Internal audit experience (asset).