Senior Quality Systems Leader, Cell & Gene Therapy

F. Hoffmann-La Roche AG; San Diego (CA); On-site; USD 115,000 - 213,000; Full time

Benefits offered by this job

Discretionary annual bonus

Job summary

Genentech, a member of the Roche group, seeks a Principal Quality Systems Specialist in San Diego to oversee pharmaceutical quality systems for Cell and Gene Therapy. You will lead QMS development, risk management, training, documentation, and data integrity, while guiding strategic initiatives and health authority interactions.

This role requires 12+ years in quality within pharma/biotech, with GxP, FDA, and EMA expertise, and strong cross-site leadership.

Qualifications

• Bachelor’s or post-graduate degree in Science, Engineering, or a related discipline.
• Minimum of 12 years of relevant quality experience in pharma/biotech.
• Hands-on experience with GxP, FDA, and EMA regulations and guidances.
• Cross-functional leadership across global operations, partners and suppliers.
• Strong problem-solving skills with adaptability and proactive communication.

Responsibilities

• Coordinate work across systems, functions, and sites to harmonize workflow.
• Lead development, review, and revision of SOPs and procedures.
• Collaborate with SMEs to determine training needs and curricula updates.
• Monitor systems implementation and ensure compliance and continuous improvement.
• Create QMS metrics and provide project/validation oversight.
• Support audits, deviation/CAPA management, and investigations.
• Improve Roche's QMS and policies to align with evolving regulations.
• Support Health Authority interactions and responses as needed.
• Ensure safety, GMP/cGTP alignment, and global cross-site collaboration.

Skills

Cross-Functional Leadership

Problem-Solving & Agility

Communication & Culture

Regulatory Expertise

Collaboration across global operations

Education

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

Tools

Veeva Vault

Job description

Genentech, a member of the Roche group, seeks a Principal Quality Systems Specialist in San Diego to oversee pharmaceutical quality systems for Cell and Gene Therapy. You will lead QMS development, risk management, training, documentation, and data integrity, while guiding strategic initiatives and health authority interactions.

This role requires 12+ years in quality within pharma/biotech, with GxP, FDA, and EMA expertise, and strong cross-site leadership.