Senior Manager, Quality Assurance
4 days ago
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treatedKyverna is recruiting a Senior Manager, Quality Assurance in its Technical Operations organization to help advance its mission to transform the treatment of autoimmunity for the benefit of patients. The ideal candidate will contribute to our goals of navigating what's next in synthetic biology, immunology and cell engineering while living our core values: bring intellectual humility, elevate each other, and stay true to why. The Senior Manager will be responsible for the effective Quality oversight of the Contract Manufacturing Organizations (CMO) partnerships for investigational product release in support of clinical trials, and ensuring CMO compliance with current Good Manufacturing Practices (GMP). ResponsibilitiesPerform batch record review and lot release of investigational product manufactured at CMO partners.Perform QA/client review and approval for internal and/or CMO Quality System records, manufacturing documents, analytical methods, and qualification/validation documentation.On-site oversight of CMO operations as needed to support the programsLiaise with Supply Chain to ensure all necessary documents/forms/records are authorized to facilitate movement of cell product to clinical sitesSupport Manufacturing to develop and monitor key performance indicators to ensure effective oversight of CMO and contract/external laboratories.Draft, review, maintain, and execute against Quality Agreements with Supplier/CMO network. Lead and drive "right the first time" performance with CMOs to ensure clinical program expectations are met.Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met as required.Work with functional leadership to design, implement and maintain Risk Based Quality Management strategies in support of Kyverna's clinical programs.Other duties as assigned by manager.RequirementsDegree (Bachelors or higher) or equivalent experience in life sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years experience in the field of cell therapies preferred.Expertise with cGMP manufacturing as well as global regulatory regulations and requirements for biopharmaceutical products and ATMPsDemonstrated ability to manage multiple complex relationships within a CMO networkExperience with electronic Quality Management SystemsExperience in conducting or hosting Quality and/or Health Authority audits.Excellent interpersonal, verbal and written communication skillsAbility to function efficiently and independently in a changing environmentAbility to operate in a Controlled/Classified Environment, including ability to successfully maintain aseptic technique and complete cleanroom gowning qualification requirements.Must be willing to travel up to ~50% of time, depending on manufacturing schedule.Ability to think critically, and demonstrated troubleshooting, problem-solving, and risk assessment skillsStrategic thinking and high emotional intelligenceManage and advance multiple projects simultaneously and dynamically reprioritize as neededDemonstrated capacity to think creatively when addressing complex situations Ability to communicate effectively with Kyverna Leadership, clinical, and development scientists, and with external business partners and Regulatory Authorities. Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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Senior Manager, Quality Assurance
4 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...
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Senior Manager, Quality Document Control
2 weeks 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...
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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...
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Senior Manager, Quality Document Control
4 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...
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Quality Systems Manager
4 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...
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Quality Systems Manager
3 weeks 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...
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Housing Program Manager
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Emeryville, California, United States St Mary's Center Full timeJob SummaryWe are seeking a highly skilled and experienced Housing Program Manager to join our team at St. Mary's Center. The successful candidate will provide leadership and accountability to an interdisciplinary team of professional and paraprofessional case managers and housing navigators working to support Seniors in becoming and remaining housed.Key...
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Senior Document Management Specialist
3 weeks ago
Emeryville, California, United States Kyverna Therapeutics Full timeJob SummaryThe Document Management Senior Specialist will play a crucial role in managing and maintaining the integrity, security, and compliance of documentation within a drug development environment at Kyverna Therapeutics. This position will oversee the administration and management of the company's Document Management System (DMS) to ensure proper...
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Manager, Quality Systems
2 weeks ago
Emeryville, United States Kyverna Therapeutics Full timeKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the...
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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...
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Emeryville, California, United States BeiGene Full timeJob SummaryThe Senior Quality Director, Commercial Small Molecule will lead the quality management process for commercial small molecule products, ensuring compliance with regulatory requirements and BeiGene standards. This role will oversee the quality team, manage quality issues, and implement effective CAPA processes.Key ResponsibilitiesLead the quality...
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Emeryville, United States Ramboll Group AS Full timeSenior Managing Consultant or Principal, DecarbonizationRamboll is a global multi-disciplinary engineering, design, and consultancy company.We have 16,500 employees worldwide, with 300 offices across 35 countries, including 59 offices in the US.Joining Ramboll means working for a company that strives to make a difference – for our employees, clients, and...
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Emeryville, United States Kyverna Therapeutics Full timeKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the...
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Senior Clinical Trials Manager
3 weeks ago
Emeryville, California, United States Kyverna Therapeutics Full timeAt Kyverna Therapeutics, we are committed to developing innovative cell therapies for patients suffering from autoimmune diseases. As a key member of our Clinical Operations team, the Senior Clinical Trials Manager will play a pivotal role in the successful execution of our clinical trials.The ideal candidate will have a strong background in clinical trial...
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Emeryville, California, United States BeiGene Full timeJob Summary:The Associate Director, DP Commercial Small Molecule role at BeiGene is responsible for ensuring the commercial small molecule products are manufactured, packed, labelled, stored and transported in a controlled way at Contract Manufacturing Organizations (CMOs) that is in accordance with the regulatory expectations and applicable Good...
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Senior Product Manager
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Emeryville, California, United States Eko Full timeEko is a leading digital health company dedicated to providing innovative solutions for healthcare professionals. We're committed to investing in our mission to ensure all patients have access to high-quality care.The Clinical Product Manager will be responsible for planning and executing our Enterprise and SMB products, specifically for the Cardiac and...
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Senior Project Engineer
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Emeryville, California, United States IPS-Integrated Project Services, LLC Full timeJob SummaryIPS is seeking a highly skilled Senior Project Engineer to join our team. As a key member of our project delivery team, you will provide technical, administrative, and subcontractor management support to Project Managers and Project Directors.Key ResponsibilitiesDevelop and maintain working knowledge of prime contract requirements and apply...
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Emeryville, California, United States LBL Full timeJob SummaryWe are seeking a highly skilled Senior Financial Analyst to join our team at Lawrence Berkeley National Lab's (LBNL) Office of the Chief Financial Officer Division. As a Senior Financial Analyst, you will be responsible for a wide range of complex analytical, modeling, and reporting functions.Key ResponsibilitiesDevelop, produce, and analyze...
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Senior Project Engineer
3 weeks ago
Emeryville, California, United States IPS-Integrated Project Services, LLC Full timeJob DescriptionAt IPS, you'll apply your knowledge, skills, and passion to make a difference in the lives of people, by solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities.We are looking for a talented Senior Project Engineer to join our dedicated team located at our project site in...
