Expert Quality Operations

About the role

The Expert Quality Operations will oversee quality aspects of monoclonal antibody manufacturing at Incyte's large‑scale bioplant in Yverdon‑les‑Bains. The role ensures compliance with cGMP, supports on‑time product supply and drives continuous improvement in collaboration with manufacturing teams.

Key responsibilities

• Provide day‑to‑day quality oversight of USP and DSP manufacturing, washing area and media/buffer preparation, including on‑floor presence in classified areas.
• Review, approve and monitor SOPs, batch records, deviations, investigations, CAPA plans and change controls to ensure regulatory compliance.
• Lead exception management, risk assessments and GEMBA activities, and support inspection readiness for health‑authority audits.
• Act as backup for the QA Operations Supervisor, ensuring continuity of QA activities during absences.

Required profile

• Degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering) preferred.
• Minimum 5 years of Quality Operations experience in pharmaceutical manufacturing.
• Strong knowledge of cGMP, USP/DSP processes and international regulatory requirements.
• Proficiency in French (written and spoken); English level preferred.

Required skills

• cGMP compliance and documentation management.
• Batch record review and approval.
• Deviation investigation and CAPA implementation.
• Change control and risk assessment.
• Inspection readiness and audit support.