Senior Manager, External Quality & CMO Partnerships

CSL Vifor; Sankt Gallen; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

CSL Vifor is seeking an experienced Senior Manager, External Supply Quality Assurance (m/f/d) to provide strategic Quality oversight for CMOs across the region and lead a small international team based in Bern and Marburg.

You will ensure robust quality systems, reliable product supply, and compliance with CSL Quality requirements, combining expertise in sterile manufacturing and EU GMP Annex 1 with strategic thinking and leadership.

Qualifikationen

• Minimum of 8 years in a GxP-regulated pharmaceutical environment.
• Hands-on GMP sterile manufacturing experience.
• In-depth knowledge of EU GMP Annex 1 in sterile manufacturing.
• Fluent English; German language skills desirable.

Aufgaben

• Lead an international team of three Quality professionals based in Bern and Marburg, providing direction and fostering collaboration across the external supply network.
• Act as senior Quality interface for CMOs, ensuring effective oversight and alignment with CSL Quality requirements.
• Manage complex CMO quality issues, provide strategic guidance, and drive CAPAs and remediation actions.
• Monitor CMO quality performance with KPIs, identify trends and implement corrective actions.
• Standardize CMO Quality Agreements to align with commercial agreements.
• Represent CSL Quality in governance forums and support regulatory inspections and reviews.

Kenntnisse

GxP compliance

Quality leadership

Quality systems

Regulatory knowledge

Stakeholder mgmt

GMP sterile

CMO collaboration

Strategic thinking

Ausbildung

University degree

Jobbeschreibung

CSL Vifor is seeking an experienced Senior Manager, External Supply Quality Assurance (m/f/d) to provide strategic Quality oversight for CMOs across the region and lead a small international team based in Bern and Marburg.

You will ensure robust quality systems, reliable product supply, and compliance with CSL Quality requirements, combining expertise in sterile manufacturing and EU GMP Annex 1 with strategic thinking and leadership.