GxP Compliance Lead – Clinical Distribution & Audit Expert

ELAN Personal AG; Kaiseraugst; Vor Ort; CHF 130.000 - 190.000; Vollzeit

Benefits dieser Stelle

Modern campus and green spaces

Central Basel location

Training and development opportunities

Zusammenfassung

Roche Switzerland is seeking a GxP Compliance Expert in Kaiseraugst/Basel to ensure quality and regulatory compliance across the Clinical Distribution Deliver organization. You will serve as SME for GxP topics, manage deviations and CAPAs, and drive training to enhance team capabilities.

The role requires 6+ years of senior experience, proficiency in German and English, and hands-on familiarity with Veeva and Cornerstone.

Qualifikationen

• Degree in a relevant field with significant senior experience.
• At least 6 years of professional experience.
• In-depth knowledge of cGMP and regulatory inspections (internal and external).
• End-to-end supply chain management including warehouse and transport.
• Strong interpersonal, organizational and prioritisation skills.
• Fluent in German and English (written and spoken).
• Proficient with Veeva, Cornerstone, MS Office, Google Apps and Visio.

Aufgaben

• Be SME for all GxP and compliance topics, including system administration (Veeva quality docs).
• Audit/Inspection SME for Deliver for non-study specific examinations.
• Manage deviations, CAPAs, changes and process improvements.
• Own Quality KPIs for Deliver and drive trend reporting.
• Lead deviation management improvement initiatives.
• Provide comprehensive compliance expertise to the business and conduct RCA.
• Maintain SOPs and other regulated documents for the department.
• Drive GxP training and develop employees' knowledge.

Kenntnisse

GxP compliance

Regulatory inspections

Root Cause Analysis

SOPs management

Quality KPI ownership

Stakeholder communication

Documentation handling

Ausbildung

BA/MS/MBA in a relevant field

Tools

Veeva

Cornerstone

MS Office

Google Apps

Visio

Jobbeschreibung

Roche Switzerland is seeking a GxP Compliance Expert in Kaiseraugst/Basel to ensure quality and regulatory compliance across the Clinical Distribution Deliver organization. You will serve as SME for GxP topics, manage deviations and CAPAs, and drive training to enhance team capabilities.

The role requires 6+ years of senior experience, proficiency in German and English, and hands-on familiarity with Veeva and Cornerstone.