Associate Director, Quality Control

vor 1 Monat

Visp, Schweiz Vaxcyte Vollzeit

**Join our Mission to Protect Humankind**

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

**WHAT** we do is every bit as important as **HOW** we do it Our work together is guided by four enduring core values:

- RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
- AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
- LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
- MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

**Summary**:
As Vaxcyte’s products progress towards late stage and commercialization, Vaxcyte is initiating development of dedicated biologics manufacturing facilities. Working closely with Process Development, Quality, Operations, and Regulatory functions, this role will be responsible for management of CMC activities related to Quality Control in order to ensure timely, compliant, secure, and uninterrupted supply of Vaxcyte’s innovative therapies. As part of the Quality Control organization for Contract Development and Manufacturing Organizations (CDMOs), your responsibilities encompass ensuring that products and services meet quality standards and regulatory requirements throughout the development and manufacturing processes.

This position will report to the Head of Quality Control of Vaxcyte Switzerland.

**Essential Functions**:

- Implement, and maintain robust quality control systems that encompass sampling, testing, documentation, and release procedures for raw materials, intermediates, and finished products.
- Writing, review and approval of documents related to analytical testing to ensure compliance with applicable regulatory and industry standards. Review and approval of technical reports to support investigations and expiry/retest periods.
- Manage the development and validation of analytical methods used for testing products. Ensure that methods are scientifically sound, reproducible, and suitable for their intended use.
- Ensure that contracted QC laboratories are equipped with appropriate instrumentation and equipment, maintained according to regulatory requirements, and calibrated regularly to ensure accuracy and reliability of test results.
- In partnership with the contract laboratories, manage method validation and transfer activities between contract laboratories, ensuring the accuracy, reliability, and consistency of test methods and results across sites.
- Assure that appropriate systems for data management, including the secure storage, retrieval, and retention of QC data and documentation are in place. Ensure that all testing activities are well-documented and comply with Good Documentation Practices (GDP).
- Review and approval of analytical data, test reports, and certificates of analysis (CoAs) generated by contract laboratories to verify accuracy, completeness, and compliance with specifications for both release and stability testing.
- Investigate and address deviations, out-of-specification (OOS) results, laboratory incidents, and customer complaints related to contract laboratory testing, collaborating with contract laboratories and internal stakeholders to implement corrective and preventive actions (CAPAs).
- Manage stability programs, regarding program design, data analysis, trending and regulatory submissions. In partnership with the contract laboratories, ensure that stability data are timely available, accurate and reliable.
- Manage the qualification and maintenance of reference standards.
- Develop and implement performance metrics to monitor the health and status of QC method performance; develop and implement improvement where indicated by the data.
- Provide technical support for product related regulatory inspections.
- Deputy for Head of Quality Control.

**Requirements**:

- Bachelor of Science with 10+ years of relevant experience in biotechnology/pharmaceutical industry.
- Excellent project management skills and experience in managing contract laboratories.
- Direct experience with analytical method development, qualification, validation and transfer as well as product characterization and analytical comparability.
- Comprehensive knowledge in cGMP and experience in multi-national

  • Associate Director, Quality Control

    vor 2 Monaten

    Visp, Schweiz Lonza Vollzeit

    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 own their careers. Their ideas, big and small,...

  • Associate Director, Project Controls Manager

    vor 5 Monaten

    Visp, Schweiz Proclinical Vollzeit

    Proclinical sucht einen Associate Director, Project Controls Manager mit einschlägiger Erfahrung zur Unterstützung von SGIE's Kapitalprojekten für neue Anlagen und Infrastruktur. Diese Position wird direkt für das Projektcontrolling und die Überwachung der Kosten-, Planungs - und Risikomanagementberichte verschiedener Projekte in allen Projektphasen...

  • Associate Director, Process Analytics

    vor 1 Monat

    Visp, Schweiz https:www.energyjobline.comsitemap.xml Vollzeit

    Associate Director, Process Analytics (HPLC) Location: Technical Operations, Quality & Manufacturing Visp, Switzerland Description We are seeking an Associate Director, Process Analytics, to oversee HPLC applications like test method development, transfer, and validation for the release testing of monoclonal antibodies, fusion proteins, and...

  • Associate Director, Process Analytics

    vor 3 Monaten

    Visp, Schweiz Kodiak Sciences Vollzeit

    Associate Director, Process Analytics (HPLC) Technical Operations, Quality & Manufacturing Visp, Switzerland Description We are seeking an Associate Director, Process Analytics, to oversee HPLC applications like test method development, transfer, and validation for the release testing of monoclonal antibodies, fusion proteins, and...

  • Associate Director, Process Analytics

    vor 4 Wochen

    Visp, Schweiz https:www.energyjobline.comsitemap.xml Vollzeit

    Associate Director, Process Analytics (HPLC) Technical Operations, Quality & Manufacturing Visp, Switzerland Description We are seeking an Associate Director, Process Analytics, to oversee HPLC applications like test method development, transfer, and validation for the release testing of monoclonal antibodies, fusion proteins, and antibody-biopolymer...

  • Associate Director, Project Controls Manager

    vor 5 Monaten

    Visp, Schweiz Lonza Vollzeit

    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. Their ideas, big...

  • Associate Director, Project Controls Manager

    vor 5 Monaten

    Visp, Schweiz Lonza Vollzeit

    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. Their ideas, big...

  • Associate Director, QA

    vor 5 Monaten

    Visp, Schweiz Lonza Vollzeit

    Associate 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...

  • QA Associate Director

    vor 6 Monaten

    Visp, Schweiz Lonza Vollzeit

    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. Their ideas, big...

  • Biologics Quality Control Specialist

    vor 4 Wochen

    Visp, Schweiz Lonza Vollzeit

    Quality Control Specialist - BiologicsAt Lonza, we're committed to delivering high-quality products and services that improve lives around the world. As a Quality Control Specialist - Biologics, you'll play a critical role in ensuring the quality of our biologic medicines. Your expertise will be essential in reviewing data generated during routine Quality...

  • Senior Director of Analytical Development

    vor 4 Wochen

    Visp, Schweiz Kodiak Sciences Vollzeit

    Job SummaryWe are seeking an experienced Associate Director, Process Analytics, to oversee HPLC applications and lead the development, transfer, and validation of HPLC test methods.Key ResponsibilitiesManage the development, transfer, and validation of HPLC test methodsSupport non-HPLC related analytical test methodsContribute to regulatory interactions and...

  • Senior Director, Quality Engineering and Project Delivery

    vor 4 Wochen

    Visp, Schweiz Lonza Vollzeit

    Quality Assurance Leadership OpportunityLonza, a global leader in life sciences, is seeking an experienced leader to join our Global Quality Engineering team. As Associate Director, Global Quality Engineering, Project Delivery Visp, you will play a critical role in ensuring the quality and compliance of our projects.Key Responsibilities:Owning all...

  • Quality Control Manager

    vor 2 Wochen

    Visp, Schweiz Lonza Vollzeit

    Senior Project Leader - Quality Control (Hybrid)At Lonza, we're seeking a skilled Senior Project Leader to manage quality control topics for the manufacture of life-saving biologic products. This role is crucial in ensuring the highest standards of quality and compliance.Key Responsibilities:Coordinate QC-related actions between BioAtrium and service...

  • Quality Assurance Expert

    Vor 7 Tagen

    Visp, Schweiz Lonza Vollzeit

    Job SummaryWe are seeking a Quality Assurance Expert - Microbiological Control to join our team in Visp, Switzerland.About the RoleIn this role, you will be responsible for ensuring the quality of our manufacturing facilities, processes, and products. You will collaborate with cross-functional teams to develop and implement contamination control strategies,...

  • Senior Director of Analytical Operations

    vor 2 Wochen

    Visp, Schweiz Kodiak Sciences Vollzeit

    Job SummaryKodiak Sciences seeks a talented Associate Director, Process Analytics to lead the development, transfer, and validation of HPLC test methods for the release testing of monoclonal antibodies, fusion proteins, and bioconjugates.Key ResponsibilitiesOversee the development and transfer of HPLC test methods, ensuring compliance with regulatory...

  • Associate Director

    vor 3 Wochen

    Visp, Schweiz Lonza Biologics Porriño SLU Vollzeit

    Associate Director / Technical Project Manager (m/f/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 exchange, we let our...

  • Associate Director

    vor 1 Monat

    Visp, Schweiz Lonza Group Ltd. Vollzeit

    Associate Director / Technical Project Manager (m/f/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 exchange, we let our people...

  • Associate Director, Infrastructure and Utilities

    vor 5 Monaten

    Visp, Schweiz Lonza Vollzeit

    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. Their ideas, big...

  • Associate Director, Global Quality Engineering, Project Delivery Visp

    vor 5 Monaten

    Visp, Schweiz Lonza Vollzeit

    Associate 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...

  • Quality Assurance Specialist for Contamination Control

    vor 2 Wochen

    Visp, Schweiz Lonza Vollzeit

    Senior QA Specialist, Microbiological Quality Assurance and Contamination ControlWe are looking for a highly skilled Senior QA Specialist to join our team in Visp, Switzerland. As a key member of our quality team, you will be responsible for ensuring the quality of our manufacturing facilities, processes, and products.Key Responsibilities:Provide quality...