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We are looking for a Head of Quality for BioAtrium, based in Visp, Switzerland. BioAtrium’s Head of Quality is responsible for all quality-related aspects of the activities undertaken at the site, in accordance with all applicable laws and regulations including quality agreements entered into with Sanofi and Lonza.

Tasks

  • Define quality vision and quality strategy based on the overall vision and strategy of BioAtrium.
  • Foster compliance, risk and science thinking to direct the quality organization towards a modern organization with patient wellbeing as a priority.
  • Develop milestone plans with defined quality initiatives and execute them to follow the quality strategy.
  • Act as a change agent, driving high Quality Standards and a culture of continuous improvement.
  • Develop talents through coaching and fostering continuous learning.
  • Maintain a compliant quality management system at BioAtrium.
  • Monitor key performance indicators to assess the efficiency of the quality system, quality culture, and appropriate staffing.
  • Assure qualified status of facility, equipment, processes, cleaning, test methods, IT infrastructure and application during the lifecycle of products, related systems and the facility.
  • Follow up on current GMP trends and ensure plans are in place to maintain BioAtrium in a state of compliance.
  • Oversee all outsourced services and manage any incoming complaints.
  • Maintain active and successful collaboration with Swissmedic to ensure the Manufacturing License for BioAtrium according to the Medicinal Products Licensing Ordinance (SR 812.212.1), including successful inspections of the BioAtrium facility.
  • Collaborate with all foreign health authorities and customer inspections to ensure the site is inspection-ready at any time.
  • Ensure smooth inspection organization, including set-up of back and front office, timely and adequate response to inspection observations, and focused follow-up on all CAPA plans.

Requirements

  • Master Degree in Life Sciences or related education.
  • Several years’ experience in leading GMP biopharmaceutical quality operations.
  • Many years’ 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.
  • Customer facing skills.
  • Representing the Joint venture to customers, regulatory inspectors and stakeholders.
  • English and German language is essential.
  • French language is an advantage.
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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.
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