Senior QA Lead - Cell Therapy & GMP Validation

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

Job summary

Lyell-Immunopharma, Inc. is seeking a Principal, Quality Assurance to provide QA leadership across product lifecycle activities in a cell therapy environment.

You will partner with Manufacturing, MSAT, Process Development, and Regulatory to support process implementation, validation, and regulatory submissions. The role emphasizes cross-functional collaboration, regulatory readiness, and continuous improvement to ensure GMP compliance and successful clinical and commercial milestones.

Qualifications

• Experience in cGMP clinical manufacturing.
• Experience with plasmid and LVV manufacturing preferred.
• Experience with electronic quality management systems (eQMS) required.
• Proven capability to oversee QA operations and workflows, ensuring timely execution, compliance, and alignment with organizational priorities.
• Ability to work effectively both independently and cross-functionally with Manufacturing, MSAT, Regulatory, Patient Operations, Supply Chain, and external partners to set goals, develop sound project plans, monitor progress, and report results.
• Excellent communication, emotional intelligence and interpersonal skills.
• Curious and proactive mindset with a continuous improvement orientation; actively seeks to understand processes, identify risks, and implement sustainable quality solutions.
• Fast learner, adaptable, and has the desire and ability to work in a fast-paced, start-up environment.
• Excellent analytical skills and scientific/technical expertise.

Responsibilities

• Provide CDMO QA oversight for PPQ activities, ensuring alignment with GMP requirements and regulatory expectations.
• Review and approve validation protocols, reports, and supporting documentation.
• Partner with CDMO, MSAT, and Process Development to define PPQ and validation strategies with CPPs & CQAs.
• Provide QA oversight during PPQ execution on the manufacturing floor.
• Assess PPQ data for completeness, accuracy; ensure conclusions are justified and support process validation.
• Ensure deviations during PPQ and validation are investigated, documented, and resolved with minimal schedule impact.
• Ensure alignment between validation activities and regulatory filings (IND/BLA).
• Act as QA SME for IND and BLA coordination activities; ensure consistency between QA documentation and regulatory submissions.
• Author and review CMC sections of regulatory submissions for GMP compliance.
• Lead readiness activities to prepare the site for regulatory inspections when applicable.
• Provide Quality oversight for deviations, CAPAs, and change controls.

Skills

cGMP in clinical manufacturing

Quality oversight

Cross-functional collaboration

Regulatory submissions support

CAPA & deviations management

Documentation & traceability

Analytical thinking

Communication skills

Continuous improvement

Education

BS in Biochemistry / Chemical Engineering / Bioengineering or related field

Tools

eQMS (Quality Management System)

Job description

Lyell-Immunopharma, Inc. is seeking a Principal, Quality Assurance to provide QA leadership across product lifecycle activities in a cell therapy environment.

You will partner with Manufacturing, MSAT, Process Development, and Regulatory to support process implementation, validation, and regulatory submissions. The role emphasizes cross-functional collaboration, regulatory readiness, and continuous improvement to ensure GMP compliance and successful clinical and commercial milestones.