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 treated
We are seeking a Manager, Quality Systems, Document Management and Training to provide quality expertise to support our Quality’s team for the development and commercialization of Kyverna’s products in compliance with relevant US, EU and ICH requirements. This role will support in the execution, development, and continuous improvement of the Document Control/Management and Training Program at Kyverna as we grow and mature organizationally. We are looking for a teammate that can partner with internal departments to support the Document Control (eDMS), Learning Management System (LMS), and Quality Management Systems (eQMS), and to implement process improvements to meet business and regulatory requirements.
This position will report to the Associate Director, Quality Systems.
Responsibilities
- Manage the Document Control and Training team and processes.
- Manage the development and implementation of controlled documents including, but not limited to: SOPs, Work Instructions, training materials, protocols, reports, templates, and reference guides.
- Ensure internal formatting standards are maintained.
- Collaborate with department managers to develop training requirements and training plans including Read and Understand, On the Job, and Instructor Led training.
- Ensure GxP training records and matrices are created and maintained.
- Train GxP personnel on documentation and training practices within the electronic document management system and electronic learning management system.
- Directly lead as well as perform, execute, and assist in the execution of daily tasks in the Document Control and Training Areas.
- Manage delivery, maintenance, and continuous improvement of GxP processes in eDMS, eLMS, and eQMS.
- Participate in system validation activities, as required.
- Generate compliance metrics and prepare routine KPI reports.
- Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
- Collaborate with site personnel to drive consistency in quality process execution.
- Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
- Perform other duties, as assigned.
Requirements
- 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.
- Experience in the use of validated computer systems for management of regulated documents and training, including electronic records and electronic signatures.
- Thorough knowledge of electronic Quality Management Systems, Learning Management Systems and Quality Documentation Systems, admin experience strongly desired.
- 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.
- A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties.
- Excellent written and verbal communication and collaboration skills with the ability to interact with all levels throughout the organization.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
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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Last updated on Sep 24, 2024