Global Quality & Compliance Manager GMP/GDP

Roche; Basel; Sur place; CHF 180 000 - 240 000; Plein temps

Résumé du poste

Roche is seeking a Global Quality Manager to safeguard product quality and regulatory compliance for global clinical trials within the IMP Distribution Network. You will apply your expertise in quality systems and GxP processes to provide guidance and oversee complex distribution quality activities.

Key responsibilities include regulatory compliance, global QA oversight, deviation management, document control, inspections, and continuous improvement across the Roche network.

Qualifications

• Proven experience in Quality Assurance within GMP/GDP.
• Bachelor's degree in science, engineering, or related field.
• Fluent in German and English, both written and spoken.

Responsabilités

• Act as the Delegate of the Swiss Responsible Person (FvP) and lead final QA decisions.
• Maintain Global QA oversight for Roche IMP Distribution Network and PTDS-L.
• Lead Deviation Management and assess product quality impact of CAPAs.

Connaissances

QA & Compliance

GxP Knowledge

Regulatory Documentation

German & English

Formation

Bachelor's degree in a relevant field

Description du poste

Roche is seeking a Global Quality Manager to safeguard product quality and regulatory compliance for global clinical trials within the IMP Distribution Network. You will apply your expertise in quality systems and GxP processes to provide guidance and oversee complex distribution quality activities.

Key responsibilities include regulatory compliance, global QA oversight, deviation management, document control, inspections, and continuous improvement across the Roche network.