Job Description
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
Position Summary
We are seeking a Sr. Specialist, Document Management & 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. The Sr Specialist, Quality Systems role will support in the execution, development, and continuous improvement of the Document Control/Management 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.
Title: Sr. Specialist, Document Management & Training
Location: Remote
Reports To: Associate Director, Quality Systems
Responsibilities
- Support day-to-day Document Control and Training processes.
- Oversee and assist with development and implementation of controlled documents including, but not limited to: SOPs, Work Instructions, training materials, protocols, reports, templates, and reference guides.
- Ensure documents meet GMP, Good Documentation Practice, enterprise formatting, and authoring standards.
- Collaborate with department managers to develop training requirements and training plans in the eLMS.
- Administer the Learning Management System (LMS), including assignment, tracking, and reporting of training curricula.
- Coordinate training assignments related to new or revised documents.
- Oversee and support generation of compliance metrics and routine KPI reports for Document Control and Training processes.
- Support inspection readiness initiatives for Document Control and Training processes.
- Train GxP personnel on documentation and training practices within the eDMS and eLMS.
- Identify gaps or trends in document control and training compliance and recommend improvements.
- Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
- Participate in system validation activities, as required.
- Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
- Perform other duties, as assigned.
Qualifications
- Bachelor’s degree in Computer Science, Life Science or related field or applicable experience.
- 4+ years in Quality Systems/Quality Assurance experience in the regulated life sciences industry.
- 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.
The national base salary range for candidates for this position is $100K to $120K annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors that may include but are not limited to quality and length of experience, education, geographic location and alignment with market data.
