Director, Quality Assurance
vor 4 Wochen
**Company Profile**:
***
Vaxcyte, headquartered in San Carlos, CA, went public in June 2020 and currently has a team of approximately 180 employees and anticipates continued, significant growth. Following equity offerings in October 2022 and April 2023, which generated over $1.1 billion in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. These financings followed positive data readouts from Vaxcyte’s Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64 and Phase 2 study in adults 65 and older. The Company believes these results support a best-in-class potential for VAX-24, which was designed to replace the current standard-of-care in adults and children. VAX-24 is being investigated for the prevention of IPD, which can be most serious for infants, young children, older adults and those with immune deficiencies or certain chronic health conditions. Given the global impact of pneumococcal disease remains significant, the public health community continues to advocate for vaccines that can offer broader protection to prevent IPD. Vaxcyte’s PCV franchise, consisting of VAX-24 and VAX-31, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease. We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
**Essential Functions**:
- Collaborates across local and global Quality Assurance teams to help provide support, assess risk and evaluate resolution to quality issues.
- Represents Quality Assurance is support of Investigations, Deviations, Change Controls, and CAPAs.
- Ensures timely and effective communication and escalation of quality issues.
- Provides oversight and guidance to external manufacturing partners with respect to GMP manufacturing, investigations and deviations and lot release activities.
- Executes the quality program and to ensure high quality products enter the supply chain.
- Leads or participates in Quality Management Review to monitor process performance, product quality and effectiveness of the quality management system.
- May review and approve quality documentation such as batch records, validation protocols, and reports for compliance.
- Provide oversight for process validation batches and evaluate commercial readiness.
- Collaborate with cross functional teams to ensure manufacture of GMP compliant products.
- Champions and fosters a positive quality compliance culture.
**Requirements**:
- BS or BA with 12 years relevant industry experience.
- Demonstrate in-depth knowledge of GMPs, FDA/EU regulations and ICH guidelines.
- Knowledge and experience in Risk Management principles.
- Knowledge in both clinical and commercial product desired.
- Strong Management and process improvement skills.
- Demonstrate excellent verbal, written, and interpersonal communication skills.
- Demonstrate experience leading and contributing through influence and working in cross functional teams.
- Comprehensive knowledge of biologics manufacturing.
- Experience with vaccine manufacturing operations preferred.
- Experience in commercial launch desired.
- Experience with overseeing GMP manufacturing in a commercial facility.
- Fluency in spoken and written English.
- Positive, proactive approach to complex quality issue.
- All Vaxcyte employees require vaccination against COVID-19.
**Reports to**: Executive Director, Quality Assurance
**Location**: Visp, Switzerland
**Compensation**:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
***
**Send resumes to**:
Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
LI-JN1
Wir haben weitere aktuelle Stellen in diesem Bereich, die Sie unten finden können
-
Director, Quality Assurance
vor 1 Woche
Visp, Schweiz Vaxcyte VollzeitCompany Profile:***Vaxcyte, headquartered in San Carlos, CA, went public in June 2020 and currently has a team of approximately 180 employees and anticipates continued, significant growth. Following equity offerings in October 2022 and April 2023, which generated over $1.1 billion in net proceeds, the Company's balance sheet is further strengthened to...
-
Associate Director, Quality Assurance
vor 1 Woche
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three 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...
-
Project Manager Quality Assurance
vor 2 Monaten
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three 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...
-
Project Manager Quality Assurance
vor 18 Stunden
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three 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...
-
Project Manager Quality Assurance
vor 1 Woche
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three 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...
-
Quality Assurance Expert
vor 1 Woche
Visp, Schweiz Arxada VollzeitArxada is a pioneering leader with a powerful legacy: Over 120 years of creating specialty chemicals and solutions that potentiate the performance of our customers and their products. Our solutions, our expertise and our support help them to perform better - to be more efficient, more effective and more sustainable. We are passionate about empowering high...
-
Director, Quality Assurance
vor 2 Wochen
Visp, Schweiz Vaxcyte VollzeitU.S. Equal Employment Opportunity information (Completion is voluntary and will not subject you to adverse treatment) Vaxcyte provides equal employment and affirmative action opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or...
-
Executive Director, Head of Quality Biologics, Visp
vor 2 Monaten
Visp, Schweiz Lonza Biologics Porriño SLU VollzeitExecutive Director, Head of Quality Biologics, Visp Today, Lonza is a global leader in life sciences operating across three 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...
-
Project Manager Quality Assurance Pcp
vor 1 Woche
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three 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...
-
Associate Director, QA
vor 1 Woche
Visp, Schweiz Lonza VollzeitAssociate Director, Global Quality Engineering, Project Delivery Visp (f/m/d) Today, Lonza is a global leader in life sciences operating across three 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...
-
Project Manager Quality Assurance
vor 3 Wochen
Visp, Schweiz Lonza VollzeitSwitzerland, VispLonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen...
-
Executive Director, Head of Quality Biologics, Visp
vor 3 Wochen
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three 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...
-
Visp, Schweiz Lonza AG VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three 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...
-
Executive Director, Head of Quality Biologics, Visp
vor 3 Wochen
Visp, Schweiz Lonza AG VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three 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...
-
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three 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...
-
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three 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...
-
Project Manager Quality Assurance Pcp
vor 2 Monaten
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three 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...
-
QA Associate Director
vor 1 Woche
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three 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...
-
Visp, Schweiz Lonza AG VollzeitSwitzerland, Visp Switzerland, VispToday, Lonza is a global leader in life sciences operating across three 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....
-
Associate Director, QA
vor 19 Stunden
Visp, Schweiz Lonza VollzeitAssociate Director,Global Quality Engineering, Project Delivery Visp (f/m/d) Today, Lonza is a global leader in life sciences operating across three 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...
