Note: The job is a remote job and is open to candidates in USA. Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. The Sr Manager, QA Operations will oversee Quality Operations across CDMOs and ensure compliance with regulatory requirements while driving quality improvements.
Responsibilities
- Service as primary Quality Assurance Point of contract for Contract Development and Manufacturing Organizations (CDMOs), providing strategic quality oversight and partnership management
- Provide end-to-end oversight of Quality Operations across CDMOs (Plasmid, Viral Vector, and Cell Therapy Manufacturing and Testing), including Master Batch Record review and approval, product disposition, and continuous improvement of QA operational processes
- Lead batch release activities for clinical and commercial products, ensuring compliance with applicable regulatory requirements and internal quality standards
- Support Qualified Person (QP) certification activities by ensuring batches meet registered specifications, regulatory requirements, and current GMP expectations
- Review and approve OOS, OOT, deviations, supplier change notifications, change controls, and related CAPAs, ensuring timely resolution and effective implementation
- Monitor and report key quality and operational metrics related to product lifecycle and product journey milestones
- Support Patient Operations in the on-boarding and continued performance of the apheresis collection centers and cell therapy labs according to program plans and strategy
- Ensure adherence to cGMP regulations, ICH guidelines, and Kyverna SOPs
- Drive and support continuous improvement initiatives to enhance quality systems, operational efficiency, compliance, and inspection readiness
- Support inspection readiness, other goals, and deliverables as required
Skills
- Bachelors or Masters in life sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or other related major
- 8+ years of pharmaceutical manufacturing and/or Quality Assurance experience
- Experience with cGMP manufacturing and GDP as well as global regulatory regulations and requirements for biopharmaceutical products and ATMPs
- Strong Project Management skills and ability to manage multiple projects simultaneously
- Independently motivated, detail oriented and good problem-solving ability
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
- Domestic and international travel required, approximately 10% (including travel to CDMOs and/or Suppliers and internal business meeting, as needed)
- Excellent verbal, written and presentation skills and effectively communicate with all levels of management
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments
- At least 2 years experience in the field of cell/gene therapies
Benefits
- This position is also eligible for bonus, benefits, and participation in Company’s stock plan.
Company Overview
Company H1B Sponsorship