GxP Compliance Expert — Hybrid Role, QA & Regulatory SME

Flexsis; Kaiseraugst; Híbrido; CHF 120.000 - 160.000; Jornada completa

Descripción de la vacante

Flexsis, on assignment with Roche in Kaiseraugst, seeks a reliable and motivated GxP Compliance Expert (m/f/d). Start ASAP, contract 12 months with possible extension 6–12 months. Hybrid work: 3 days on site, 2 days from home.

Fluent in German and English required. You will act as SME for GxP and compliance topics, support regulatory inspections, manage deviations and CAPAs, own quality KPIs, and oversee SOPs and regulated documents.

Formación

• Degree in a relevant field with significant senior experience.
• At least 6 years of professional experience.
• Extensive knowledge of cGMP standards and regulatory inspections (FDA/EMA).
• Strong end-to-end supply chain understanding: warehousing, transportation, logistics, and clinical supply.
• Excellent interpersonal, organizational, and prioritization skills with a customer focus.
• Fluent in German and English (written and spoken).
• Proficient with Google Workspace, MS Office, Visio, Veeva, and Cornerstone.

Responsabilidades

• Serve as SME for GxP and compliance topics, including system administration (Veeva quality docs).
• Audit/Inspection SME for Deliver non-study examinations.
• Process deviations, CAPAs, changes, and process improvements.
• Own Quality KPI reporting for Deliver.
• Lead deviation management improvement initiatives.
• Provide comprehensive compliance expertise and RCA for quality issues.
• Manage SOPs and regulated documents across departments.
• Produce trend reports on Quality and Compliance.
• Implement GxP training and develop employee knowledge.

Conocimientos

GxP compliance

Supply chain mgmt

German & English

MS Office / Google apps

Stakeholder comms

Educación

BA/MS/MBA in a relevant field (e.g. SCM, Pharmacy, Biology, Chemistry)

Herramientas

Veeva

Cornerstone

Visio

MS Office

Google Apps

Descripción del empleo

Flexsis, on assignment with Roche in Kaiseraugst, seeks a reliable and motivated GxP Compliance Expert (m/f/d). Start ASAP, contract 12 months with possible extension 6–12 months. Hybrid work: 3 days on site, 2 days from home.

Fluent in German and English required. You will act as SME for GxP and compliance topics, support regulatory inspections, manage deviations and CAPAs, own quality KPIs, and oversee SOPs and regulated documents.