Manager Deviation & QMS Deployment (70%)

Proclinical Staffing; Bern; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Proclinical Staffing in Bern, Switzerland, seeks a Manager Deviation & QMS Deployment (70%). You will own the local deviation management system and drive QMS improvements with global stakeholders, ensuring regulatory compliance and sustainable improvements.

The role requires GMP experience, strong analytical skills, and fluency in German and English to communicate with auditors and teams across sites. The position is based at the Bern site and offers collaboration with international quality

Qualifikationen

• Degree in pharmacy, chemistry, biology, or related field.
• Experience in GMP-regulated environments (QA, Compliance, or QMS).
• Familiarity with deviation management, investigations, and RCA.
• Experience creating and maintaining SOPs and delivering trainings.
• Strong analytical and communication skills.
• German and English proficiency in writing and speaking.

Aufgaben

• Oversee the local Deviation Management System as Local Process Champion for Bern.
• Develop SOPs and work instructions ensuring regulatory compliance.
• Support global QMS processes with local and global teams.
• Coordinate deviations, assist root cause analyses, promote investigations.
• Lead or support quality improvement projects harmonizing processes.
• Prepare for audits/regulatory inspections and address findings.
• Generate KPIs and trends and present metrics to stakeholders.
• Conduct training and requalifications within the area.

Kenntnisse

GMP experience

Quality Assurance

Compliance

QMS deployment

Deviation management

Root cause analysis

SOP development

Training & requalification

Stakeholder management

German language

English language

Ausbildung

Pharmacy/ Chemistry/ Biology degree

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.