Senior QA Projects Lead – Biopharma, cGMP

Lonza Group Ltd.; Oberwallis; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Agile work culture

Inclusive workplace

Competitive compensation

Benefits package

Lonza benefits site

Zusammenfassung

Lonza Group Ltd. is seeking a Senior QA Specialist (f/m/d) for QA Projects in Visp, Switzerland.

This role will own all quality responsibilities across manufacturing processes for clinical and commercial biotech products, and act as QA representative in project/tech transfer activities to ensure cGMP compliance. The role involves reviewing SOPs and batch records, assessing product changes, and leading investigations of deviations and customer complaints while mentoring junior staff and

Qualifikationen

• Academic degree in Chemistry/Biotechnology/Life Science or related field.
• Solid GMP experience in the pharmaceutical industry, preferably in QA.
• General knowledge of biopharmaceutical manufacturing processes and analytical methods.
• Experience interacting with health authorities (Swissmedic, FDA).
• Ability to manage projects and ensure quality compliance on timelines.
• Business fluent English; good German is an advantage.

Aufgaben

• Own all quality related responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply.
• Represent QA in project/tech transfer organizations for new biotech manufacturing processes.
• Review and final release of SOPs, Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports.
• Perform assessments for product-related changes and provide change controls for approval to customers where required.
• Ensure deviations are investigated and documented; manage investigations of customer product complaints.

Kenntnisse

QA experience

GMP knowledge

English fluency

Team collaboration

Project coordination

Ausbildung

Academic degree in Chemistry/ Biotechnology/ Life Science

Jobbeschreibung

Lonza Group Ltd. is seeking a Senior QA Specialist (f/m/d) for QA Projects in Visp, Switzerland.

This role will own all quality responsibilities across manufacturing processes for clinical and commercial biotech products, and act as QA representative in project/tech transfer activities to ensure cGMP compliance. The role involves reviewing SOPs and batch records, assessing product changes, and leading investigations of deviations and customer complaints while mentoring junior staff and