QA Lab Qualification Lead — GMP/CSV & Digitalization

Lonza Group Ltd.; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Competitive compensation

Benefits by role/location

Zusammenfassung

Lonza Group Ltd. in Visp, Switzerland seeks an experienced QA Manager, Lab Qualification (f/m/d) to lead qualification activities for laboratory equipment and systems.

You will drive continuous improvement, digitalization and compliance within QC laboratories while representing QA in audits and inspections. The role combines hands-on QA oversight with strategic initiatives, requiring GMP expertise, strong communication skills, and fluency in German and English.

Qualifikationen

• Significant GMP experience within QA, Qualification, CSV and/or QC.
• Strong knowledge of equipment qualification and CSV principles.
• Experience leading improvement initiatives in GMP-regulated environments.
• Fluent in German and English.

Aufgaben

• Serve as QA representative and SME for laboratory equipment qualification including CSV.
• Drive development, implementation and continuous improvement of qualification strategies, standards and lifecycle approaches.
• Lead improvement and digitalization projects, including implementation of new systems and tools.
• Review and approve qualification lifecycle documentation, including qualification plans and reports, risk assessments and validation deliverables.
• Provide QA oversight for changes, deviations, investigations, CAPAs and effectiveness checks related to laboratory equipment and systems.
• Represent QA Lab Qualification during customer audits, regulatory inspections and internal audits.
• Partner with QC, CSV, IT and other stakeholders to ensure compliant execution of qualification activities.
• Support and deputize the QA Lab Qualification Lead in strategic initiatives, decision-making, coaching and development of best practices while maintaining involvement in routine qualification activities.

Kenntnisse

Communication

Stakeholder management

Leadership

Risk-based decisions

Ausbildung

Life Sciences/ Chemistry/ Biotechnology degree

Tools

CSV (Computerized System Validation)

Jobbeschreibung

Lonza Group Ltd. in Visp, Switzerland seeks an experienced QA Manager, Lab Qualification (f/m/d) to lead qualification activities for laboratory equipment and systems.

You will drive continuous improvement, digitalization and compliance within QC laboratories while representing QA in audits and inspections. The role combines hands-on QA oversight with strategic initiatives, requiring GMP expertise, strong communication skills, and fluency in German and English.