Head of QA Bioatrium

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

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.

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.

Key Responsibilities

The Head of Quality has the authority to decide on all Quality-relevant decisions and holds the following permanent responsibilities and accountabilities:

Quality strategy and Leadership at BioAtrium AG

The Head of Quality defines quality vision and quality strategy.

The quality vision and quality strategy will be based on the overall vison and strategy of BioAtrium.

The quality vision will foster compliance, risk and science thinking to direct the quality organization towards a modern organization having eventually the patient's wellbeing in top of their mind.

On periodic basis, milestone plans with defined quality initiatives to ensure to follow the quality strategy will be defined and subsequently executed.

Acts as a change agent, driving high Quality Standards and a culture of continuous improvement.

Develops talents through coaching and fostering continuous learning.

Quality Management System of BioAtrium

Head of Quality maintains a compliant quality management system at BioAtrium:

Monitoring of key performance indicators to assess the efficiency of the quality system, of the quality culture, and of appropriate staffing.

Assures qualified status of facility, equipment, processes and cleaning, test methods, IT infrastructure and application during the lifecycle of products, of related systems and of the facility.

Follows up on current GMP trends and ensures that plans are in place to maintain BioAtrium in a state of compliance.

Oversight of all outsourced services as well as management of any incoming complaints.

Inspection and regulatory agencies

The Head of Quality maintains an 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.

This includes also the collaboration with all foreign health authorities as well as any customer inspections to ensure the site is inspection-ready at any time. Ensure a smooth inspection organization including the set-up of back and front office, timely and adequate response to inspection observations and focused follow-up on all CAPA plans.

Key Requirements, Qualifications, Skills & Behavior

• 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.

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.