Sr Manager QA Operations, Cell Therapy & GMP
Overview
You will own QA operations for CDMOs across plasmid, viral vector, and cell therapy manufacturing, ensuring batch release and compliance for clinical and commercial products. You partner with the Sr Director to lead quality oversight, batch disposition, and continuous improvement, while supporting QP certification and apheresis center onboarding. This role drives inspection readiness and quality metrics in a fast-paced cell therapy environment. You will work with CDMOs, GMP, and ICH guidelines, shaping quality systems for transformative autoimmune treatments.
What You'll Do9
- 1Serve as primary QA point of contact for CDMOs, providing strategic quality oversight and partnership management.
- 2Oversee end-to-end quality operations across CDMO sites, including Master Batch Record review and approval, product disposition, and continuous improvement.
- 3Lead batch release activities for clinical and commercial products, ensuring compliance with regulatory requirements and internal quality standards.
- 4Support QP certification by ensuring batches meet registered specifications, regulatory requirements, and current GMP expectations.
- 5Review and approve OOS, OOT, deviations, supplier change notifications, change controls, and related CAPAs, ensuring timely resolution.
- 6Monitor and report key quality and operational metrics for product lifecycle and journey milestones.
- 7Support Patient Operations in onboarding and performance of apheresis collection centers and cell therapy labs.
- 8Ensure adherence to cGMP regulations, ICH guidelines, and Kyverna SOPs.
- 9Drive continuous improvement initiatives to enhance quality systems, operational efficiency, compliance, and inspection readiness.
Requirements9
- 18+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years in cell/gene therapies preferred.
- 2Bachelor's or Master's in life sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or related field.
- 3Experience with cGMP manufacturing and GDP as well as global regulatory requirements for biopharmaceutical products and ATMPs.
- 4Strong project management skills and ability to manage multiple projects simultaneously.
- 5Independently motivated, detail oriented, and good problem-solving ability.
- 6Highly collaborative team player who fosters open communication and cooperation between stakeholders.
- 7Domestic and international travel required, approximately 10%.
- 8Excellent verbal, written, and presentation skills, effectively communicating with all levels of management.
- 9Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
Salary Insight
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