The Head of Quality has the authority to decide on all Quality-relevant decisions and holds the following permanent responsibilities and accountabilities:
Most Responsible Quality Person on-site (FvP):
Responsibilities include, but not limited to:
Overall responsibility for disposition of batches.
Ensure escalation of critical quality issuers.
Oversee Quality Management review process including annual quality plan.
Ensures Quality System meets regulatory expectations, including approval of SOPs for key quality systems.
Approve annual product reviews.
Manage recall process.
Approves inspection and audit reports.
Approves QA agreements with customers.
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.
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.
Customer facing skills.
Representing the Joint venture to customers, regulatory inspectors and stakeholders.
English and German language is essential.
French language is an advantage.
Benefits
Health insuranceVision insurance
Additional Information
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.
The incumbant will be the designated responsible person (Fachtechnische verantwortliche Person) for BioAtrium AG according to the Medicinal Products Licensing Ordinance, SR 812.212.1 (Arzneimittel Bewilligungsverordnung).
Lonza · Switzerland