Global GxP Quality & Compliance Leader

Sobi - Swedish Orphan Biovitrum AB (publ); Basel; Vor Ort; CHF 200.000 - 320.000; Vollzeit

Zusammenfassung

Sobi is seeking a Global GxP Quality Systems Head to lead across the organization in developing and implementing an enterprise-wide Quality and Compliance strategy. The role covers end-to-end regulated processes across the product lifecycle with global and local accountability, including audits, inspections and risk management.

The candidate will drive a culture of quality excellence, manage budgets, and collaborate with senior leaders to ensure compliance with global health authority

Qualifikationen

• Master degree in pharmacy or related field.
• 15+ years experience in global pharmaceutical quality systems.
• 10+ years leadership experience.
• GMP/GxP, GMP, GCP and GVP knowledge.
• Experience with virtual pharma company setup and digital QMS.

Aufgaben

• Lead Global GxP Compliance & Quality Systems team.
• Drive a culture of quality and compliance across the product lifecycle.
• Ensure effectiveness of Global Sobi Quality Management System.
• Oversee quality system adherence to current GxP and regulatory requirements.
• Define budgets and timelines for quality processes.
• Provide strategic direction to teams in GxP activities.
• Identify improvement areas with Global Process Owners and implement changes.
• Develop and sustain risk management processes for timely risk reporting.
• Define and conduct Annual Audit Programs and manage audits/inspections.
• Report quality system performance to Senior Leaders and drive preventive actions.

Kenntnisse

Leadership

Communication

Cross-functional collaboration

Stakeholder management

Problem solving

Ausbildung

Master degree in pharmacy or related field

Tools

Veeva

Jobbeschreibung

Sobi is seeking a Global GxP Quality Systems Head to lead across the organization in developing and implementing an enterprise-wide Quality and Compliance strategy. The role covers end-to-end regulated processes across the product lifecycle with global and local accountability, including audits, inspections and risk management.

The candidate will drive a culture of quality excellence, manage budgets, and collaborate with senior leaders to ensure compliance with global health authority