Quality Systems Leader - Cell & Gene Therapy

Genentech; San Diego (CA); On-site; USD 115,000 - 213,000; Full time

Job summary

Genentech in San Diego, CA is seeking a Principal Quality Systems Specialist to provide leadership and expert oversight of pharmaceutical quality systems within the Cell and Gene Therapy team. You will drive the development, implementation, and ongoing management of the QMS, risk and change management, training, documentation and data integrity.

You will lead cross-functional collaboration, support audits, deviations, CAPA and health authority interactions, and contribute to strategy for CGT

Qualifications

• Bachelor's or post-graduate degree in science, engineering or related field.
• Minimum 12 years of relevant quality experience in pharma/biotech, CGT preferred.
• Hands-on experience developing, implementing, auditing quality programs under GxP, FDA, EMA.
• Strong cross-functional influence, negotiation and collaboration across globals.
• Proven problem-solving, adaptability, and clear strategic-vs-tactical thinking.

Responsibilities

• Coordinate work across systems, functions, and sites to harmonize workflow.
• Lead development, review, and revision of SOPs and procedural documents.
• Collaborate with SMEs to determine training needs and update curricula.
• Monitor system implementation and assist in execution, performance and effectiveness.
• Create routine and ad hoc Quality Management Review metrics for Quality Systems.
• Provide project and validation oversight related to Quality Systems applications.
• Support internal and external audits, deviation/CAPA management, complaints investigations.
• Improve QMS and quality manual, policies, and procedures to stay current with regs.
• Provide timely support for Health Authority interactions and responses.
• Perform tasks consistent with safety policies, cGTP/GMP and guidance.
• Contribute to Genentech's strategy for CGT industrialization.

Skills

Quality systems leadership

Regulatory compliance

Cross-functional leadership

Problem-solving & agility

Communication skills

Education

Bachelor's or Post-Graduate degree in Science, Engineering, or related discipline

Tools

Veeva Vault

Job description

Genentech in San Diego, CA is seeking a Principal Quality Systems Specialist to provide leadership and expert oversight of pharmaceutical quality systems within the Cell and Gene Therapy team. You will drive the development, implementation, and ongoing management of the QMS, risk and change management, training, documentation and data integrity.

You will lead cross-functional collaboration, support audits, deviations, CAPA and health authority interactions, and contribute to strategy for CGT