Global Director, Quality Assurance & Manufacturing

albedis; Zürich; Vor Ort; CHF 140.000 - 200.000; Vollzeit

Zusammenfassung

albedis seeks a Director of Quality Assurance to lead the global quality and manufacturing strategy from its Zürich HQ. You will shape compliance programs, supervise QA and production, and drive continuous improvement across international operations.

Ideal candidates bring a robust pharma QA background, QP certification (or Deputy QP), and a proven track record with CDMOs, supplier relationships, and complex regulatory inspections. Expect up to 50% travel across Europe.

Qualifikationen

• Degree in Pharmacy, Life Sciences, Chemistry or related field.
• Qualified Person (QP) certification strongly preferred; Deputy QP acceptable.
• Extensive leadership in pharmaceutical manufacturing, QA, and regulated production.
• Strong manufacturing background with external network experience.
• Experience managing CDMOs, quality agreements, and supplier relationships.
• Fluent in German and English; able to lead stakeholders across Europe.
• Willingness to travel up to 50% across multiple sites in Europe.

Aufgaben

• Lead the QA & Production Management organization, incl. people leadership, resource planning, budget accountability, KPI management, and strategic initiatives.
• Define and execute global quality and compliance strategy (GMP, GDP, ISO 13485; regulatory requirements; inspections).
• Own and continuously improve the global QMS; oversee document control, change control, training, deviations, CAPAs, supplier qualification, complaints, risk management, and Product Quality Reviews.
• Drive quality oversight across manufacturing instructions, compliant processes, Master Batch Records, validations, change controls, risk assessments, and production documentation.
• Lead regulatory inspections, internal audits, supplier audits, and partner audits; ensure remediation and ongoing compliance.
• Direct global deviation, investigation, and CAPA activities with root cause analysis and risk-based decisions.
• Establish internal/external quality standards; translate GMP, GDP, ISO requirements into practical processes.
• Oversee manufacturing network performance, CDMO management, transfers, technology transfers, and new product integration.
• Foster a culture of quality, operational excellence, safety, and cross-functional collaboration; travel as needed.

Kenntnisse

Leadership

Quality assurance

Regulatory compliance

GMP knowledge

CAPA & deviations

Risk management

CDMO management

Supplier management

Cross-functional leadership

Ausbildung

Pharmacy/Life Sciences/Chemistry degree

Jobbeschreibung

albedis seeks a Director of Quality Assurance to lead the global quality and manufacturing strategy from its Zürich HQ. You will shape compliance programs, supervise QA and production, and drive continuous improvement across international operations.

Ideal candidates bring a robust pharma QA background, QP certification (or Deputy QP), and a proven track record with CDMOs, supplier relationships, and complex regulatory inspections. Expect up to 50% travel across Europe.