Senior Supplier Quality Lead – GMP Compliance & Audits

Lonza; Stein (AR); Hybrid; Vertraulich; Vollzeit

Zusammenfassung

Lonza is seeking a Supplier Quality expert to drive qualification activities for GMP-relevant suppliers across Basel and Stein, interfacing with Supply Chain, Manufacturing, and Regulatory teams. You will review complex documentation and ensure compliance with global standards.

The role focuses on supplier qualification, quality agreements, and supplier-related CAPAs, with interactions at customer audits and inspections. On-site with some remote flexibility.

Qualifikationen

• GMP-regulated pharma experience required with focus on quality and compliance.
• 3+ years in QA or Supply Chain with supplier management.
• Experience with supplier qualification, quality control, and sterile manufacturing desirable.
• Audits exposure (e.g., Swissmedic, FDA) is a strong advantage.
• Fluency in English; German is a plus.

Aufgaben

• Manage qualification and lifecycle of GMP-relevant suppliers for materials, services, and equipment across Basel and Stein.
• Serve as primary Quality contact for supplier qualification, partnering with Supply Chain, Manufacturing, QC, Engineering, and stakeholders.
• Review, approve, and maintain supplier documentation and manage complex supplier qualification cases.
• Drive CAPAs, deviations, quality escalations, and change requests with global teams including Switzerland and India.
• Represent Supplier Quality during customer audits and authority inspections, presenting supplier management processes.

Kenntnisse

Supplier management

Quality Assurance

Cross-functional collaboration

GMP knowledge

Audits experience

English fluency

German language

Ausbildung

Academic degree in chemistry/biology/pharmaceutical sciences or related field

Jobbeschreibung

Lonza is seeking a Supplier Quality expert to drive qualification activities for GMP-relevant suppliers across Basel and Stein, interfacing with Supply Chain, Manufacturing, and Regulatory teams. You will review complex documentation and ensure compliance with global standards.

The role focuses on supplier qualification, quality agreements, and supplier-related CAPAs, with interactions at customer audits and inspections. On-site with some remote flexibility.