Director Quality Assurance

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

Our client is seeking an exceptional Director, Quality Assurance to lead and shape their global quality and manufacturing strategy. Based at their headquarters in Zurich, this is a highly visible leadership position with significant influence across the organization and direct impact on the future growth, compliance, and operational excellence of the clients business.

This role combines strategic leadership with hands‑on operational oversight and is ideally suited to an experienced Quality or Manufacturing leader who thrives in complex international environments.

If you are an accomplished pharmaceutical quality and manufacturing leader who thrives on ownership, challenges convention, and delivers meaningful results, we invite you to play a pivotal role in shaping our clients future growth and success.

What You Will Deliver

• Lead the Quality Assurance & Production Management organization, including personnel leadership, resource planning, budget accountability, KPI management, and execution of strategic business initiatives.
• Define and execute the global quality and compliance strategy, ensuring continued compliance with GMP, GDP, ISO 13485, regulatory requirements, licenses, certifications, and inspection readiness.
• Own and continuously improve the global Quality Management System (QMS), overseeing key quality processes including document control, change control, training, deviations, CAPAs, supplier qualification, complaints, risk management, and Product Quality Reviews.
• Drive quality oversight across manufacturing instructions, ensuring compliant manufacturing processes, Master Batch Records, validations, change controls, risk assessments, and production documentation.
• Lead regulatory inspections, internal audits, supplier audits, and partner audits, ensuring effective preparation, execution, remediation, and continuous compliance improvement.
• Direct global deviation, investigation, and CAPA activities, ensuring robust root cause analysis, risk‑based decision making, and sustainable corrective actions.
• Establish and strengthen internal and external quality standards, proactively translating evolving GMP, GDP, and ISO requirements into practical and effective business processes.
• Oversee manufacturing network performance, including CDMO management, manufacturer qualification, manufacturing transfers, technology transfers, process improvements, and integration of new products and manufacturing partners.
• Foster a culture of quality, operational excellence, continuous improvement, and safety through leadership, coaching, training, and effective cross‑functional collaboration across the business.

What You Bring

• Degree in Pharmacy, Life Sciences, Chemistry or a related scientific discipline.
• Qualified Person (QP) certification strongly preferred; candidates with Deputy QP experience and the potential to assume QP responsibilities are highly desirable.
• Significant leadership experience within pharmaceutical manufacturing, quality assurance, and regulated production environments.
• Strong manufacturing background with a practical understanding of production operations and external manufacturing networks.
• Demonstrated experience managing CDMOs, quality agreements, complex supplier relationships, and manufacturing transfers.
• Fluent German and English with the ability to effectively lead stakeholders across Switzerland, Germany, and international markets.
• Strong international leader with proven success navigating multicultural, global environments.
• Hands‑on, pragmatic, and action‑oriented; driving results through collaboration and accountability.
• Willingness to travel up to 50% across multiple sites in Europe.