Expert Vendor Qualification

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

Zusammenfassung

Proclinical Group in Bern, Switzerland, is seeking an Expert, Vendor Qualification to support GxP supplier qualification activities. You will lead vendor qualification processes, including document reviews and audit execution, ensuring compliance with Swissmedic, FDA and EU guidelines.

The role emphasizes quality oversight, risk-based decision making, and collaboration with internal and external stakeholders to qualify and maintain a robust vendor base for GxP-relevant equipment and services.

Qualifikationen

• Degree in life sciences or engineering; MSc preferred.
• Experience in quality assurance and regulatory compliance with GxP guidelines.
• Familiarity with biologics manufacturing processes.
• Proficiency in planning, document reviews, and audits of GxP vendors.
• Strong risk-based decision making and knowledge of GMP/regulations.

Aufgaben

• Execute GxP supplier qualification activities.
• Lead vendor qualification processes including document review and audits.
• Ensure qualification of vendors providing GxP-relevant equipment and services.
• Act as a Quality Delegate and Change Coordinator for Vendor Qualification Change Controls.
• Maintain overview of qualified and to-be-qualified vendors for the site.

Kenntnisse

GxP compliance

Quality Assurance

Audit execution

Vendor qualification

Regulatory knowledge

Communication skills

Stakeholder management

English fluent

Ausbildung

Master's degree in life sciences or engineering

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 Expert, Vendor Qualification 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

• Execute GxP supplier qualification activities.
• 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.

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