Manager Deviation & QMS Deployment (70%)

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

Do you thrive on solving complex quality challenges and turning investigations into lasting improvements?

Proclinical is seeking a Manager Deviation & QMS Deployment (70%) to join a dynamic team in Switzerland. In this role, you will take ownership of the local deviation management system and contribute to the continuous improvement of the Quality Management System (QMS). Collaborating with both local and global stakeholders, you will ensure quality processes are harmonized, regulatory requirements are met, and sustainable improvements are implemented.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities

• Oversee the local Deviation Management System and act as the Local Process Champion for the Bern site.
• Continuously develop processes, SOPs, and work instructions related to deviation management, ensuring regulatory compliance.
• Support change management, complaint management, and other global QMS processes in close collaboration with local and global quality teams.
• Coordinate and manage complex deviations, assist with root cause analyses, and promote the use of effective investigation methods.
• Lead or support improvement projects aimed at harmonizing and optimizing quality processes and standards.
• Prepare for audits and regulatory inspections, present your areas of responsibility to auditors, and assist in addressing audit observations.
• Generate KPI and trending reports, derive improvement measures, and present relevant quality metrics to stakeholders.
• Conduct training sessions and requalifications within your area of responsibility, supporting team members in applying QMS processes effectively.

Key Skills and Requirements

• Degree in pharmacy, chemistry, biology, or a related scientific field.
• Professional experience in a GMP-regulated environment, ideally in Quality Assurance, Compliance, or Quality Management Systems.
• Familiarity with deviation management, investigations, and root cause analysis is advantageous.
• Experience in creating and maintaining SOPs, as well as conducting training and requalifications.
• Strong analytical, structured, and solution-oriented approach with the ability to communicate complex topics clearly.
• Excellent communication and stakeholder management skills, with a collaborative mindset.
• Proficiency in German and English, both written and spoken.

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