Vendor Qualification Expert

Proclinical Staffing; Bern; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Proclinical Staffing is seeking a Vendor Qualification Expert to support GxP supplier qualification activities, leading document reviews, audits, and change controls to ensure regulatory compliance for GMP-relevant equipment and services.

You will act as Quality Delegate, manage qualified vendors, coordinate risk-based decisions, and collaborate with internal and external stakeholders across global sites, with English as the working language.

Qualifikationen

• Degree in life sciences or engineering.
• MSc or equivalent preferred.
• Experience in quality assurance and regulatory compliance with GxP guidelines (Swissmedic, FDA, EU).
• Knowledge of GMP and global regulatory requirements.

Aufgaben

• Lead vendor qualification processes, including document review and audit execution.
• Ensure the qualification of vendors providing GxP-relevant equipment and services.
• Act as a Quality Delegate and Change Coordinator for Vendor Qualification Change Controls.
• Establish and maintain an overview of qualified and to-be-qualified vendors for the site.

Kenntnisse

Quality assurance

Regulatory compliance

GxP knowledge

Risk-based decisions

Stakeholder collaboration

Project-based work

English fluency

Ausbildung

Life sciences or engineering degree

MSc or equivalent preferred

Jobbeschreibung

Ready to lead Vendor Qualification that bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!

Proclinical is seeking an Vendor Qualification Expert to support GxP supplier qualification activities. In this role, you will lead vendor qualification processes, including document reviews and audit execution, ensuring compliance with regulatory standards. This position focuses on maintaining high-quality standards for vendors providing GxP-relevant equipment and services.

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:

• Lead vendor qualification processes, including document review and audit execution.
• Ensure the qualification of vendors providing GxP-relevant equipment and services.
• Act as a Quality Delegate and Change Coordinator for Vendor Qualification Change Controls.
• Establish and maintain an overview of qualified and to-be-qualified vendors for the site.

Key Skills and Requirements:

• Degree in life sciences or engineering; an advanced degree (MSc or equivalent) is preferred.
• Experience in quality assurance and regulatory compliance with GxP guidelines (e.g., Swissmedic, US FDA, TGA, EU).
• Familiarity with biologics manufacturing processes.
• Proficiency in quality oversight of GxP-compliant vendor qualification processes, including planning, documentation review, and audits.
• Strong decision-making skills in a risk-based quality environment.
• Deep knowledge of GMP and global regulatory requirements (e.g., FDA, EU, and other GxP regulations).
• Excellent communication and interpersonal skills, with the ability to influence across organizational levels.
• Effective collaboration with internal and external stakeholders.
• Experience in project-based work.
• Fluent in English, both spoken and written.