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Document Management Senior Specialist
2 months 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 treated
The 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. The individual will ensure that all records, whether in digital or physical formats, are accurately controlled, maintained, and compliant with regulatory standards (e.g., FDA, EMA, ICH, GxP) throughout the product lifecycle. This position will provide leadership, oversight, and expertise in document management systems (DMS), support audits and inspections, and work cross-functionally with departments including Quality Assurance, Regulatory Affairs, and Clinical Operations.
Responsibilities
- Oversee the administration and management of the company's Document Management System (DMS) to ensure proper document versioning, approval workflows, and timely access to documents.
- Ensure the consistent organization, storage, archiving, and retrieval of all documentation related to drug development, clinical trials, regulatory submissions, and quality control processes.
- Monitor document lifecycle processes, ensuring the integrity and accuracy of all records.
- Ensure that all documents comply with regulatory requirements and company Standard Operating Procedures (SOPs), Good Documentation Practices (GDP), and global regulatory standards such as GxP (Good Manufacturing Practice, Good Clinical Practice, etc.).
- Assist in preparing for and supporting regulatory audits and inspections by ensuring documents are readily accessible and meet all compliance standards.
- Serve as a subject matter expert (SME) on the electronic document management system (EDMS), ensuring proper configuration, user access, and functionality.
- Identify opportunities to enhance document management processes through system upgrades, automation, and best practices to improve efficiency and compliance.
- Provide training and guidance to employees and cross-functional teams on document control processes, the use of EDMS, and the importance of maintaining data integrity and regulatory compliance.
- Act as a primary contact for troubleshooting issues related to the EDMS and document workflows.
- Collaborate with key stakeholders, including Regulatory Affairs, Quality Assurance, Clinical Operations, and IT teams, to ensure alignment on document management strategies.
- Lead or participate in cross-functional project teams to drive improvements in document management processes and systems.
- Lead internal audits of the document management system and assist with preparing for external audits or regulatory inspections.
- Ensure readiness and appropriate documentation for inspections by health authorities (e.g., FDA, EMA) and other regulatory agencies.
- Develop and monitor key performance indicators (KPIs) for document management activities to ensure timely document processing, accessibility, and compliance.
- Provide regular reports and updates to senior leadership on document management activities and system performance.
- Bachelor's degree in life sciences, regulatory affairs, information management, or a related field. A Master's degree is preferred.
- 2-5 years of experience in document management within the pharmaceutical, biotechnology, or drug development industry, with a strong understanding of regulatory requirements.
- Experience with EDMS platforms such as Veeva Vault, MasterControl, or equivalent.
- In-depth knowledge of regulatory standards (FDA, EMA, ICH, GxP) and Good Documentation Practices (GDP).
- Strong project management skills, with the ability to lead and implement process improvements.
- Excellent communication and interpersonal skills, with the ability to work collaboratively across departments.
- High attention to detail and a commitment to maintaining document integrity and compliance.
- Experience in Document Management or Quality Management Systems.
- Experience with data migration or system implementation projects.
- Familiarity with electronic Trial Master Files (eTMF) or regulatory submission documentation (eCTD).
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
