Principal QA Lead — Cell Therapy & Regulatory Submissions

Lyell Immunopharma; Bothell (WA); On-site; USD 150,000 - 185,000; Full time

Benefits offered by this job

Equity incentive plan

Job summary

Lyell Immunopharma is seeking a Principal, Quality Assurance to lead QA oversight across the cell therapy product lifecycle. Based in Bothell, WA, you will partner with Manufacturing, MSAT, Process Development and Regulatory to support process validation, tech transfer and regulatory submissions.

You will serve as Quality SME for IND/BLA coordination, author and review CMC sections, and ensure inspection readiness with a focus on continuous improvement and robust validation strategies.

Qualifications

• Experience in cGMP clinical manufacturing.
• Experience with plasmid and LVV manufacturing preferred.
• Experience with electronic quality management systems (e.g. deviations, CAPAs, change management).
• Proven ability to oversee QA operations and workflows.

Responsibilities

• Provide QA leadership across product lifecycle in a cell therapy environment.
• Act as Quality SME for IND/BLA coordination and regulatory submissions.
• Author/review CMC sections to ensure GMP compliance.
• Drive readiness for regulatory inspections and continuous improvement.

Skills

cGMP experience

LVV & plasmid

QMS systems

cross-functional leadership

regulatory submissions

analytical skills

Education

BS in bioengineering/biochemistry/chemical engineering

Job description

Lyell Immunopharma is seeking a Principal, Quality Assurance to lead QA oversight across the cell therapy product lifecycle. Based in Bothell, WA, you will partner with Manufacturing, MSAT, Process Development and Regulatory to support process validation, tech transfer and regulatory submissions.

You will serve as Quality SME for IND/BLA coordination, author and review CMC sections, and ensure inspection readiness with a focus on continuous improvement and robust validation strategies.