QA Lab Qualification Lead – GMP/CSV & Digitalization

Lonza; Schweiz; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Inclusive workplace

Competitive compensation

Benefits program

Global benefits portal

Zusammenfassung

Lonza is hiring an experienced QA Manager, Lab Qualification (f/m/d) to lead qualification activities in Visp, Switzerland. The role combines hands-on QA oversight with strategic improvement initiatives and drives digitalization and compliance excellence.

You will act as QA representative for laboratory equipment qualification, lead lifecycle strategies, coordinate improvement projects, and provide oversight for deviations, CAPAs and audits. Fluent German and English are required.

Qualifikationen

• Academic degree in Life Sciences/Chemistry/Biotechnology or related discipline.
• Significant GMP experience within QA, Qualification, CSV and/or QC.
• Strong knowledge of equipment qualification and computerized system validation principles.
• Proven experience leading improvement initiatives in a GMP-regulated environment.
• Good understanding of cGMP requirements and Data Integrity principles.
• Excellent communication and stakeholder management skills.
• Ability to make risk-based decisions and independently drive complex initiatives.
• Fluent German and English language skills are required.

Aufgaben

• Serve as QA representative and SME for qualification of laboratory equipment including CSV.
• Drive development, implementation and continuous improvement of qualification strategies and lifecycle approaches.
• Lead and coordinate improvement and digitalization projects, including new systems and tools.
• Review and approve qualification lifecycle documentation, including plans and reports, risk assessments and validation deliverables.
• Provide QA oversight for changes, deviations, investigations, CAPAs and effectiveness checks.
• 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 and development of best practices.

Kenntnisse

QA management

GMP experience

Stakeholder mgmt

Risk-based decisions

Communication

Ausbildung

Life Sciences / Chemistry / Biotechnology degree

Jobbeschreibung

Lonza is hiring an experienced QA Manager, Lab Qualification (f/m/d) to lead qualification activities in Visp, Switzerland. The role combines hands-on QA oversight with strategic improvement initiatives and drives digitalization and compliance excellence.

You will act as QA representative for laboratory equipment qualification, lead lifecycle strategies, coordinate improvement projects, and provide oversight for deviations, CAPAs and audits. Fluent German and English are required.