Senior Manager, QA Operations

Jobtailor; Emeryville (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

Jobtailor is seeking an experienced Senior QA Leader to provide strategic quality oversight across CDMOs for plasmid, viral vector, and cell therapy manufacturing. You will manage batch release, QP collaboration, and continuous QA improvements.

You will review deviations, CAPAs, and change controls, ensure GMP alignment, and participate in inspection readiness. Travel ~10% and strong cross-functional collaboration are expected.

Qualifications

• 8+ years of pharmaceutical manufacturing and/or QA experience, with 2+ years in cell/gene therapies.
• Experience with cGMP manufacturing and GDP; familiarity with global biopharma regs.
• Strong project management and ability to manage multiple projects.
• Excellent communication and collaboration across stakeholders.

Responsibilities

• Provide strategic QA oversight for CDMOs across plasmid, viral vector, and cell therapy manufacturing.
• Lead batch release activities for clinical and commercial products in compliance with regs.
• Support QP certification and ensure batches meet specs and GMP expectations.
• Review and approve OOS/OOT, deviations, change controls, CAPAs; ensure timely resolutions.
• Monitor quality metrics and drive continuous improvement of QA operations.
• Support inspection readiness and program plans for patient operations and labs.
• Ensure adherence to cGMP, ICH, and Kyverna SOPs.
• Travel approximately 10% to CDMOs and suppliers.

Skills

Quality Assurance

Project Management

cGMP & GDP

Regulatory Compliance

Stakeholder Communication

Cross-functional Collaboration

Education

Bachelor's or Master's in life sciences

Job description

Responsibilities

• Service as primary Quality Assurance Point of contact 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.

Requirements

• 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, with at least 2 years experience in the field of cell/gene therapies preferred.
• 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.