Quality Systems Manager
1 month ago
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our innovative therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases.
We are seeking a highly skilled Quality Systems Manager to provide quality expertise to support the development and commercialization of our products in compliance with relevant US, EU, and ICH requirements. The successful candidate will be responsible for actively managing and reporting on quality systems activities related to Deviations, Investigations, CAPAs, Change Controls, and Quality Metrics.
Key Responsibilities- Manage processes and SOPs for Deviations, Investigations, CAPA, Change Control, and Quality Metrics.
- Provide hands-on expertise in the day-to-day management of QMS records in our eDMS.
- Responsible for monitoring overall quality system effectiveness and continuous improvements.
- Create and deliver training associated with QMS programs and eQMS functionality.
- Compile, evaluate, and prepare quality metrics for routine KPI reports.
- Perform trending of KPIs to assist in identifying potential risks and supporting continuous improvement.
- Adhere to all cGMPs, compliance/regulatory mandates, and quality requirements.
- Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
- Bachelor's degree in Computer Science, Life Science, or related field or applicable experience.
- A minimum of 8 years of relevant experience in the pharmaceutical/biotechnology industry with at least 6+ years in Quality Systems/Quality Assurance.
- First-hand experience in managing and reviewing quality system records (e.g., deviation, CAPA, investigation, change control).
- Experience in the use of validated computer systems for management of regulated quality management system records.
- Experience with Dot Compliance, preferred.
- Experience developing improvements to electronic Quality Systems.
- Strong software proficiency with Microsoft Suite and other desktop applications.
- Ability to manage multiple projects in a dynamic environment with attention to detail.
Kyverna Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other legally protected status. EOE/AA/Vets
-
Quality Systems Manager
2 weeks ago
Emeryville, California, United States Kyverna Therapeutics Full timeQuality Systems ManagerKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing innovative cell therapies for patients suffering from autoimmune diseases.Our therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and...
-
Quality Systems Manager
1 week ago
Emeryville, California, United States Kyverna Therapeutics Full timeQuality Systems ManagerKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases.The company's therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and...
-
Senior Manager, Quality Assurance
2 weeks ago
Emeryville, California, United States Kyverna Therapeutics Full time{"title": "Senior Manager, Quality Assurance", "content": "Transforming Autoimmune Disease TreatmentKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our innovative therapeutic platform leverages advanced T cell engineering to suppress and...
-
Senior Manager, Quality Document Control
5 days ago
Emeryville, California, United States BioSpace, Inc. Full timeJob Title: Senior Manager, Quality Document ControlJob Summary:The Senior Manager, Quality Document Control, will oversee 4DMT's Quality Document Control Program, ensuring it is executed in an efficient, compliant, and inspection-ready manner. This role can be in-person or hybrid, with regular on-site attendance at 4DMT's Emeryville...
-
Waste Management Systems Designer
1 month ago
Emeryville, California, United States American Trash Management, Inc. Full timeJob OverviewAt American Trash Management, Inc., we are seeking a skilled Waste Management Systems Designer to join our team. In this role, you will be responsible for developing innovative solutions for trash-related projects across various sectors, including residential, retail, industrial, healthcare, and educational developments.Key...
-
Learning Management System Administrator
2 weeks ago
Emeryville, California, United States BeiGene Full timeJob SummaryWe are seeking a highly skilled Learning Management System Administrator to join our team at BeiGene. The successful candidate will be responsible for providing technical support and administration of our Site-Specific training portal - learning management system (LMS).Key ResponsibilitiesSupport the global training process of the Study Specific...
-
Business Systems Group Manager
6 days ago
Emeryville, California, United States LBL Full timeJob SummaryWe are seeking a highly skilled Business Systems Group Manager to join our team at LBL. The successful candidate will be responsible for leading the Business Systems Group, providing strategic direction and oversight to ensure the effective delivery of business systems solutions.Key ResponsibilitiesLead the Business Systems Group, providing...
-
Emeryville, California, United States 4D Molecular Therapeutics Full timeJob Summary:The Senior Manager, Quality Document Control, will oversee 4DMT's Quality Document Control Program, ensuring it is executed in an efficient, compliant, and inspection-ready manner. This role can be in-person or hybrid, with regular on-site time at 4DMT's Emeryville office.Responsibilities:Quality Document Control Operations / Document Management...
-
Director of Policy and Quality Management
5 days ago
Emeryville, California, United States BeiGene Full timeThe Director of Comparator Purchasing, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain vision and strategy, providing leadership over the comparator purchase strategy and timely delivery management.Ensures organization effectively manages relationships with procurement and vendors as needed and acts as point of escalation for...
-
Senior Manager, Quality Document Control
2 weeks ago
Emeryville, California, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly experienced Senior Manager, Quality Document Control to join our team at BioSpace, Inc. This role will be responsible for managing our Quality Document Control Program, ensuring that all quality-controlled documents are properly reviewed, finalized, and obsoleted in an efficient, compliant, and inspection-ready manner.Key...
-
CRM System Administrator
2 weeks ago
Emeryville, California, United States Centre For Neuro Skills Full timeJob SummaryThe CRM Application Specialist will play a critical role in supporting company growth by enhancing and managing the CRM system and data from business applications. This position will be responsible for implementing, supporting, and optimizing Salesforce Health Cloud for the organization.Key ResponsibilitiesAdminister CRM daily operations, monitor...
-
Director of Business Systems
1 month ago
Emeryville, California, United States Tanium Full timeAbout the RoleThe Director of Business Systems at Tanium is a key leadership position responsible for driving the strategy, development, and implementation of technology systems supporting Sales and Marketing functions. This role requires a strong understanding of Salesforce, integration systems, and Agile methodologies.Key ResponsibilitiesDevelop and...
-
Emeryville, California, United States Metagenomi Full timeJob Title: Head of Analytical Development and Quality ControlMetagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise...
-
Emeryville, California, United States 4D Molecular Therapeutics Full timeJob Summary:The Senior Manager, Quality Document Control, will oversee 4DMT's Quality Document Control Program, ensuring it is executed in an efficient, compliant, and inspection-ready manner. This role will manage the program's operations, document management, and compliance with GxP concepts and guidelines. The ideal candidate will have 8+ years of...
-
Senior Solid Waste Systems Designer
2 weeks ago
Emeryville, California, United States American Trash Management, Inc. Full timeJob OverviewAmerican Trash Management, Inc. is seeking a skilled CAD Designer to develop trash equipment systems for various projects. The ideal candidate will work closely with the Design Manager and Project Managers to deliver efficient and code-compliant designs.Key Responsibilities:Develop solid waste and loading logistics systems by interpreting...
-
Electrical Systems Engineer
6 days ago
Emeryville, California, United States unspun Full timeAbout the RoleWe are seeking an experienced Electrical Engineer to design, develop, and deploy electronic assemblies and electrical systems for our revolutionary 3D weaving technology. As a key member of our team, you will refine, optimize, and scale the electrical components of our 3D weaving machines, with a strong focus on field deployment and...
-
Electrical Systems Engineer
1 month ago
Emeryville, California, United States unspun Full timeElectrical Engineer Job DescriptionWe are seeking an experienced Electrical Engineer to refine, optimize, and deploy the electrical systems that power our VegaTM 3D weaving machines. As a key member of our team, you will work across multiple disciplines to realize the world's first 3D woven products on the market.Key Responsibilities:Design and develop...
-
Director of Business Systems
4 weeks ago
Emeryville, California, United States Tanium Full timeAbout the RoleWe are seeking a highly experienced and skilled Director of Business Systems to join our team at Tanium. As a key member of our leadership team, you will be responsible for developing and executing a vision for our Sales and Marketing technologies, ensuring they align with our business goals and objectives.The ideal candidate will have a strong...
-
Electrical Systems Engineer
2 weeks ago
Emeryville, California, United States unspun inc. Full timeAbout the RoleWe are seeking an experienced Electrical Engineer to join our team at unspun Inc. in the San Francisco Bay Area. As a key member of our engineering team, you will be responsible for designing, developing, and deploying electronic assemblies and electrical systems for our revolutionary 3D weaving technology.Key ResponsibilitiesDesign and develop...
-
Director of Business Systems
1 month ago
Emeryville, California, United States Tanium Full timeAbout the RoleWe are seeking a highly experienced and skilled Director of Business Systems to join our team at Tanium. As a key member of our leadership team, you will be responsible for developing and executing a vision for our Sales and Marketing technologies, ensuring they align with our business goals and objectives.The ideal candidate will have a strong...
