Lead Deviation & QMS Deployment (GMP) – Switzerland

Proclinical Group; Bern; Vor Ort; CHF 120.000 - 180.000; Teilzeit

Zusammenfassung

Proclinical Group in Bern, Switzerland, seeks a Manager Deviation & QMS Deployment (70%) to own the local deviation management system and contribute to the continuous improvement of the Quality Management System. The role involves collaborating with local and global stakeholders to harmonize processes, meet regulatory requirements, and drive sustainable improvements.

Ideal candidates will have a GMP-regulated QA background, experience developing SOPs, conducting trainings, and coordinating

Qualifikationen

• Bachelors or higher in pharmacy, chemistry, biology or related science.
• Experience in GMP-regulated QA or Quality Management Systems.
• Familiarity with deviation management, investigations and root cause analysis.
• Experience creating SOPs and conducting training/requalifications.
• Strong analytical, structured, and clear communication skills.
• Excellent communication and stakeholder management.

Aufgaben

• Oversee the local Deviation Management System and act as Local Process Champion.
• Develop and maintain SOPs, processes, and work instructions for deviation management.
• Support change, complaint, and global QMS processes with local and global teams.
• Coordinate complex deviations, assist root cause analyses.
• Lead or support improvement projects to harmonize quality processes.
• Prepare for audits and regulatory inspections; assist with audit observations.
• Generate KPI and trend reports and present quality metrics to stakeholders.
• Conduct training and requalifications within area of responsibility.

Kenntnisse

GMP experience

QA management

Deviation management

SOP development

Root cause analysis

Training delivery

Stakeholder mgmt

German & English

Ausbildung

Science degree (pharmacy/chemistry/biology)

Jobbeschreibung

Proclinical Group in Bern, Switzerland, seeks a Manager Deviation & QMS Deployment (70%) to own the local deviation management system and contribute to the continuous improvement of the Quality Management System. The role involves collaborating with local and global stakeholders to harmonize processes, meet regulatory requirements, and drive sustainable improvements.

Ideal candidates will have a GMP-regulated QA background, experience developing SOPs, conducting trainings, and coordinating