Senior QA Lead, Raw Materials & Drug Substance Release

Incyte; Yverdon-les-Bains; Vor Ort; CHF 130.000 - 180.000; Vollzeit

Zusammenfassung

Incyte is seeking a QA Oversight professional to lead quality oversight for Raw Materials and Drug Substance release. You will supervise related quality events, ensure GMP and regulatory compliance, and collaborate with manufacturing, QC and supply chain functions.

The role requires strong experience in cGMP and QA systems, with emphasis on investigations, CAPA, and change control, while fostering a culture of quality and ethics across Bioplant operations in Waadt, Switzerland.

Qualifikationen

• Thorough knowledge of cGMP, cGDP and global regulatory requirements.
• Strong interpersonal and cross-functional collaboration skills.
• Excellent verbal and written communication with structured presentation ability.
• Compliance-focused with pragmatic, risk-based quality approach.

Aufgaben

• Collect, review and complete records for Raw Materials batch review and disposition.
• Collect, review and complete records for Drug Substance batch review, disposition and shipping.
• Provide QA representative oversight for major changes to starting materials, Drug Substance, QC testing and manufacturing processes.
• Approve LIMS master data changes and maintain quality documentation (SOPs, WI, specifications).
• Ensure QA oversight for all quality events within the area of responsibility.
• Support investigations, deviations and CAPA discussions with product expertise.
• Promote quality and compliance initiatives and maintain the Quality System.
• Assist Health Authorities inspections readiness as SME in area of expertise.

Kenntnisse

Quality oversight

GMP compliance

Documentation

CAPA management

Ausbildung

Bachelor's degree in natural or applied sciences

Tools

LIMS

Jobbeschreibung

Incyte is seeking a QA Oversight professional to lead quality oversight for Raw Materials and Drug Substance release. You will supervise related quality events, ensure GMP and regulatory compliance, and collaborate with manufacturing, QC and supply chain functions.

The role requires strong experience in cGMP and QA systems, with emphasis on investigations, CAPA, and change control, while fostering a culture of quality and ethics across Bioplant operations in Waadt, Switzerland.