Chief Quality Leader – Biopharma GMP & QC Strategy

Lonza; Stalden (VS); Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza, a global leader in life sciences, is seeking a Head of Quality for BioAtrium based in Visp, Switzerland. The role oversees all quality-related activities at the site, ensuring compliance with GMP and regulatory requirements and coordinating with Lonza and Sanofi agreements.

You will lead quality strategy, manage the Quality Management System, drive continuous improvement, and partner with regulatory authorities to support inspections and product quality for biologics operations.

Qualifikationen

• Master Degree in Life Sciences or related education.
• Several years' of experience in leading GMP biopharmaceutical quality operations.
• Many years' of experience leading multi-disciplinary teams in pharma, vaccines or biopharmaceuticals.
• Demonstrated leadership of site management teams.
• Start-up experience of manufacturing facilities or businesses.
• Expert in Quality understanding of Drug Substance (ICH Q7) and understanding current trends.
• Expert in GMP manufacturing of biopharmaceutical Drug Substances.
• Knowledge of development and technology transfer of therapeutic protein processes.
• Trained in Operational Excellence in a GMP environment.
• Quality and GMP compliance mindset.
• Representing the Joint venture to customers, regulatory inspectors and stakeholders.
• English and German language is essential.
• French language is an advantage.

Aufgaben

• Define quality strategy and lead BioAtrium's quality function.
• Maintain a compliant quality management system at BioAtrium.
• Monitor KPIs to assess efficiency of the quality system and staffing.
• Ensure facility, equipment, processes, testing methods and IT systems are compliant.
• Oversee outsourced services and manage investigations/ CAPA.
• Collaborate with Swissmedic and other health authorities for inspections.

Jobbeschreibung

Lonza, a global leader in life sciences, is seeking a Head of Quality for BioAtrium based in Visp, Switzerland. The role oversees all quality-related activities at the site, ensuring compliance with GMP and regulatory requirements and coordinating with Lonza and Sanofi agreements.

You will lead quality strategy, manage the Quality Management System, drive continuous improvement, and partner with regulatory authorities to support inspections and product quality for biologics operations.