QA Lab Qualification Lead – GMP, CSV & Digitalization

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Flexible benefits

Competitive compensation

Career development

Inclusive work environment

Zusammenfassung

Lonza is seeking an experienced QA Manager, Lab Qualification (f/m/d) to join the Visp QA Lab Qualification team. The role blends hands-on QA oversight with leadership of strategic improvements, digitalization and compliance excellence.

You will drive qualification strategies, lifecycle approaches, and coordination across QC, CSV, IT and other stakeholders, ensuring robust documentation and audits readiness.

Qualifikationen

• Academic degree in Life Sciences, Chemistry, Biotechnology or related field.
• Significant GMP experience within QA, Qualification, CSV and/or QC.
• Strong knowledge of equipment qualification and computerised system validation principles.
• Proven ability to lead improvement initiatives in a GMP-regulated environment.
• Good understanding of cGMP and Data Integrity principles.
• Excellent communication and stakeholder management skills.
• Fluent German and English required.

Aufgaben

• Serve as QA representative and SME for qualification of laboratory equipment including CSV.
• Drive development and implementation of qualification strategies and lifecycle approaches.
• Lead and coordinate improvement and digitalization projects and new systems implementations.
• Review and approve qualification plans, reports, risk assessments and validation deliverables.
• Provide QA oversight for changes, deviations, investigations, CAPAs and effectiveness checks.
• Represent QA Lab Qualification during audits and regulatory inspections.
• Partner with QC, CSV, IT and other stakeholders to ensure compliant qualification activities.
• Support and deputize QA Lab Qualification Lead in strategic initiatives while remaining involved in routine qualification activities.

Kenntnisse

Communication

Stakeholder mgmt

GMP knowledge

German fluency

English fluency

Ausbildung

Life Sciences/ Chemistry/ Biotechnology degree

Jobbeschreibung

Lonza is seeking an experienced QA Manager, Lab Qualification (f/m/d) to join the Visp QA Lab Qualification team. The role blends hands-on QA oversight with leadership of strategic improvements, digitalization and compliance excellence.

You will drive qualification strategies, lifecycle approaches, and coordination across QC, CSV, IT and other stakeholders, ensuring robust documentation and audits readiness.