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Join the Quality Assurance team in Visp to lead quality, compliance, and regulatory standards across biopharmaceutical customer and facility projects. In this role, you will contribute to delivering life-changing medicines to patients worldwide through direct oversight and cross-functional leadership. This is a fully site-based position, supporting close, real-time collaboration and technical precision in manufacturing medicines to the highest quality and safety standards.
Tasks
- Serve as the quality and compliance authority for biopharmaceutical manufacturing processes across clinical and commercial customer projects.
- Review and approve critical cGMP documentation, including Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, and Material Specifications.
- Drive the resolution of deviations, out-of-specifications, and customer complaints using structured root cause analysis and CAPA management.
- Evaluate product-related changes and assess their impact on regulatory filings (FDA, Swissmedic), managing change control approvals directly with external customers.
- Represent QA within cross-functional project and tech transfer teams to ensure seamless implementation of product safety and quality standards.
- Provide quality oversight for site and facility project initiatives to maintain optimal compliance across IBEX operations.
- Train, mentor, and guide junior quality professionals, fostering continuous development and supporting site-wide cGMP training programs.
Requirements
- Academic degree in Chemistry, Biotechnology, Life Sciences, or a related scientific discipline.
- Solid professional experience in the GMP-regulated biopharmaceutical or pharmaceutical industry, ideally in a Quality Assurance or Regulatory Affairs capacity.
- Practical knowledge of biopharmaceutical manufacturing processes, technical transfers, and analytical methods.
- Familiarity with interacting with health authorities such as Swissmedic and the FDA, alongside a strong grasp of regulatory filings.
- Demonstrated experience managing deviations, change controls, CAPAs, and direct customer interactions.
- Excellent organizational, prioritization, and project management skills with the ability to thrive in a fast-paced environment.
- Business-fluent English skills are required; proficiency in German is considered a strong advantage.
Benefits
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
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Über uns
Lonza Group AG ist ein international tätiges Unternehmen für die Pharma-, Biotech- und Life-Science-Industrie. Das Unternehmen entwickelt und produziert Wirkstoffe, biopharmazeutische Produkte sowie spezialisierte Lösungen und unterstützt Kunden von der frühen Entwicklung bis zur industriellen Herstellung. Zudem stellt Lonza chemische und biotechnologische Komponenten für Anwendungen in Gesundheit, Ernährung und weiteren Industrien her.