Senior Manager, External Supply Quality & CMO Partnerships

CSL; Bern; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

CSL is seeking an experienced Quality leader to oversee External Supply Quality Assurance for contract manufacturers in Bern and Marburg. The role focuses on strategic quality oversight, robust systems, and reliable product supply across CMOs.

You will lead a small international team, manage complex quality issues, support regulatory inspections and drive standardization across the external network with an emphasis on sterile manufacturing and EU GMP Annex 1 compliance.

Qualifikationen

• University degree in a relevant scientific, technical or business discipline.
• Minimum of 8 years in a GxP-regulated pharmaceutical environment.
• Strong GMP manufacturing experience in sterile production.
• Knowledge of EU GMP Annex 1 and regulatory expectations.

Aufgaben

• Lead an international team of three Quality professionals in Bern and Marburg.
• Provide strategic Quality oversight for CMOs and ensure robust systems.
• Manage complex quality issues, investigations and CAPAs.
• Monitor KPI performance and drive corrective actions.

Kenntnisse

GxP compliance

CMO management

Sterile manufacturing

EU GMP Annex 1

Quality leadership

Regulatory inspections

Stakeholder management

Change management

Team leadership

Quality systems

Ausbildung

University degree in science/engineering

Jobbeschreibung

CSL is seeking an experienced Quality leader to oversee External Supply Quality Assurance for contract manufacturers in Bern and Marburg. The role focuses on strategic quality oversight, robust systems, and reliable product supply across CMOs.

You will lead a small international team, manage complex quality issues, support regulatory inspections and drive standardization across the external network with an emphasis on sterile manufacturing and EU GMP Annex 1 compliance.