Senior QC Compliance Specialist — Data Integrity & Audits

Incyte Corporation; Yverdon-les-Bains; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Incyte Corporation in Yverdon-les-Bains, Switzerland, seeks a Senior Specialist QC Compliance to support the Manager QC Compliance & Support in ensuring QC processes meet regulatory expectations and Incyte requirements.

The role covers deviations, investigations, CAPA, change controls, data integrity, software validation, and audit trail review, plus training, inspections readiness, and collaboration with QA and QC teams.

Qualifikationen

• 3–5 years of quality control/compliance experience in biotech/pharma.
• Experience with deviations, CAPA and change control processes.
• Strong understanding of cGMP and data integrity principles.
• Proficient using LabWare, LIMS or similar systems.

Aufgaben

• Act as compliance SME for QC; ensure adherence to regulations and company policies.
• Coordinate deviations, investigations, CAPAs, and change controls across QC.
• Support QA collaboration and inspection readiness activities in QC scope.
• Monitor data integrity, implement DI risk analysis, and report trends.
• Lead or support training on quality compliance topics for the team.
• Prepare and review quality documents and SOPs; support audits.

Kenntnisse

Quality systems

Root cause analysis

Troubleshooting

cGMP environment

Ausbildung

MSc in Biotechnology

Tools

LabWare

LIMS

GMAO/CMMS

Jobbeschreibung

Incyte Corporation in Yverdon-les-Bains, Switzerland, seeks a Senior Specialist QC Compliance to support the Manager QC Compliance & Support in ensuring QC processes meet regulatory expectations and Incyte requirements.

The role covers deviations, investigations, CAPA, change controls, data integrity, software validation, and audit trail review, plus training, inspections readiness, and collaboration with QA and QC teams.