GxP Quality Assurance & Vendor Qualification Lead

We make it GmbH; Bern; Vor Ort; CHF 115.000 - 140.000; Vollzeit

Zusammenfassung

CSL Behring AG in Bern seeks an experienced Quality professional to lead GxP vendor qualification and ensure regulatory compliance across global guidelines. You will coordinate audits, review documentation, and collaborate with site stakeholders to maintain high quality standards.

The role requires a life sciences or engineering degree, 5+ years in pharma, and excellent communication skills in English. On-site position in Bern with exposure to GMP activities and change control processes.

Qualifikationen

• Degree in life sciences and/or engineering.
• Advanced degree (M.Sc. or equivalent) preferred.
• 5+ years in pharmaceutical industry or equivalent.
• Experience in quality assurance and regulatory compliance with GxP, Swissmedic, FDA, TGA, EU.
• Experience in GxP vendor qualification processes, including audits.
• Knowledge of GMP and global regulatory requirements.
• Strong communication and cross-organizational influence.
• Fluent in English (spoken and written).

Aufgaben

• Execute GxP supplier qualification activities.
• Lead vendor qualification including document review and audit execution.
• Ensure qualification of vendors providing GxP-relevant equipment and services.
• Act as Quality Delegate / Change Coordinator for Vendor Qualification Change Controls.
• Establish and Maintain Overview of already Qualified and to be Qualified Vendors for Site BRN.

Kenntnisse

GxP knowledge

Quality assurance

Regulatory compliance

Audit execution

Vendor qualification

Documentation review

Communication skills

Project management

English proficiency

Ausbildung

Life sciences or engineering degree

M.Sc. or equivalent preferred

Jobbeschreibung

CSL Behring AG in Bern seeks an experienced Quality professional to lead GxP vendor qualification and ensure regulatory compliance across global guidelines. You will coordinate audits, review documentation, and collaborate with site stakeholders to maintain high quality standards.

The role requires a life sciences or engineering degree, 5+ years in pharma, and excellent communication skills in English. On-site position in Bern with exposure to GMP activities and change control processes.