GMP & QA Director — Clinical-Stage Quality Leadership

IDEAYA Inc; South San Francisco (CA); On-site; USD 200,000 - 247,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

401k

ESPP

Wellness programs

Stock option awards

Job summary

IDEAYA Biosciences Inc. is seeking a Director of Good Manufacturing Processes, Quality Assurance to lead GMP QA oversight across drug products and biologics programs from toxicology through Phase 3.

The role drives phase-appropriate GMP compliance, risk management, and regulatory readiness, onsite at South San Francisco four days a week. Reporting to the Senior Director, GMP & GPA, you will collaborate across CMC, Regulatory Affairs, IT, and external CDMOs, shaping quality strategy and ensuring

Qualifications

• BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree strongly preferred.
• Minimum 12 years QA experience in biopharma, with 8+ years in development-stage programs.
• Minimum 5 years direct GxP experience (GMP/GCP/GPV/GLP) in regulated environment.

Responsibilities

• Provide strategic and operational QA leadership for development programs from toxicology through Phase 3.
• Lead QA oversight of GMP activities for clinical trial materials and CDMOs.
• Maintain QA input for regulatory submissions (IND, IMPD, BLA) and lifecycle changes.
• Develop and maintain SOPs governing development QA activities.
• Support regulatory inspections and audits with timely resolution of findings.

Skills

QA leadership

GxP compliance

Regulatory readiness

CDMOs oversight

Audits & deviations

Quality systems

Clinical manufacturing

CMC collaboration

Education

BS in Life Sciences, Chemistry, Engineering or related; MS/PhD/PharmD preferred

Tools

Computer systems validation

Job description

IDEAYA Biosciences Inc. is seeking a Director of Good Manufacturing Processes, Quality Assurance to lead GMP QA oversight across drug products and biologics programs from toxicology through Phase 3.

The role drives phase-appropriate GMP compliance, risk management, and regulatory readiness, onsite at South San Francisco four days a week. Reporting to the Senior Director, GMP & GPA, you will collaborate across CMC, Regulatory Affairs, IT, and external CDMOs, shaping quality strategy and ensuring