Senior QA Lead - Biologics, Cell Culture & Compliance

Intuit, Inc.; Pleasanton (CA); Sur place; USD 170 000 - 230 000; Plein temps

Résumé du poste

Intuit, Inc. is seeking a senior QA leader to drive quality management across biologics, cell culture, and media production.

You will own CLD workflows, supplier quality, audits, and validation strategies to ensure GMP readiness and continuous improvement. You will partner with R&D and operations to embed quality by design, ALCOA+ data integrity, and phase-appropriate compliance from development to scale-up.

Qualifications

• 6+ years in Quality within biologics, cell culture, media, CDMO, or adjacent life-sciences manufacturing.
• 2+ years in a QA lead/manager role.
• Hands-on CLD/cell culture workflows and pilot-scale media production experience.
• Strong command of cGMP principles, ISO 9001/13485, ICH Q7/Q9, data integrity (ALCOA+), and phase-appropriate compliance for R&D to clinical scale-up.
• Proven track record standing up QMS elements (deviations/CAPA, change control, doc control, batch review, training).
• Exposure to equipment/utilities qualification (cleanrooms, HVAC, PW/DI water, cold rooms), EM programs, and quality risk management.
• Excellent cross-functional communication; comfortable working with both scientists and operators.
• Bachelor’s in life sciences or engineering; advanced degree a plus.

Responsabilités

• Lead QMS elements and ensure readiness for GMP, including deviations, CAPA, change control, and document control.
• Oversee CLD/cell culture workflow QA oversight, including cell banking qualification, traceability, and reference standards control.
• Manage small-scale media production QA oversight, batch records, in-process specs, and environmental monitoring.
• Qualify raw-material suppliers, set inbound inspection plans, and maintain ASL.
• Lead internal audits and support client audits; develop validation/qualification strategies for GMP readiness.
• Coach R&D/Operations on quality best practices and drive continuous improvement.

Connaissances

Quality leadership

Cell culture QA

GMP compliance

Data integrity (ALCOA+)

QMS implementation

Cross-functional communication

Formation

Bachelor’s in life sciences or engineering

Advanced degree preferred

Outils

eQMS/LIMS

EM programs

Description du poste

Intuit, Inc. is seeking a senior QA leader to drive quality management across biologics, cell culture, and media production.

You will own CLD workflows, supplier quality, audits, and validation strategies to ensure GMP readiness and continuous improvement. You will partner with R&D and operations to embed quality by design, ALCOA+ data integrity, and phase-appropriate compliance from development to scale-up.