Global QA Manager - IMP Distribution & Compliance

F. Hoffmann-La Roche AG; Basel; Hybrid; CHF 140,000 - 200,000; Full time

Benefits offered by this job

Protein & Regulatory training

Job summary

Roche in Basel seeks a Global Quality Manager to oversee QA for the IMP Distribution Network and related regulatory functions. You will drive deviations, CAPAs, and system ownership for critical quality documentation while ensuring GMP/GDP compliance across global clinical trials.

The role requires robust knowledge of GxP, a science/engineering degree, and fluency in German and English to support regulatory documentation and inspections.

Qualifications

• Experience in Quality Assurance with GMP/GDP compliance.
• Bachelor level degree in a relevant field (science/engineering).
• Fluent in German and English for regulatory documentation.

Responsibilities

• Regulatory compliance: act as the delegated Swiss Responsible Person guardian and final QA decision maker.
• Global oversight of Roche IMP Distribution Network and PTDS-L.
• Lead deviation management with product quality impact assessments and CAPA review.
• System owner for quality docs and change records across internal and external documents.
• Inspect management: drive GxP inspections and audits.
• Quality decision-making for Temperature Excursion and expert opinions in trials.

Skills

QA & Compliance

GxP knowledge

Regulatory docs

German language

English language

Education

Bachelor's degree in science/engineering

Job description

Roche in Basel seeks a Global Quality Manager to oversee QA for the IMP Distribution Network and related regulatory functions. You will drive deviations, CAPAs, and system ownership for critical quality documentation while ensuring GMP/GDP compliance across global clinical trials.

The role requires robust knowledge of GxP, a science/engineering degree, and fluency in German and English to support regulatory documentation and inspections.