Senior Director, Product Quality & Compliance

Regulatory Jobs; Foster City (CA); On-site; USD 210,000 - 272,000; Full time

Benefits offered by this job

Company-sponsored medical, dental, and

Vision and life insurance plans

Job summary

Gilead Sciences Inc. is seeking a seasoned Quality leader to drive product quality strategy across development, manufacturing, and regulatory teams. You will lead cross-functional PQT activities, apply risk-based evaluation, and ensure compliant data and processes.

The role focuses on enabling successful regulatory filings, managing inspections (PAI/PLI), and ensuring inspection readiness while balancing quality with business needs.

Qualifications

• 12+ years of relevant experience with a bachelor’s degree in science, or 10+ years with an advanced degree.
• Direct experience with regulatory health authority submissions (IND, NDA, BLA, MAA) and inspections.
• Broad experience across analytical product characterization, process validation, drug development, packaging/labeling, and biologics.

Responsibilities

• Provide quality leadership on cross-functional teams in a matrix environment.
• Drive product quality strategies across development, transfers, and regulatory filings.
• Lead PQT activities to align on quality strategy and deliverables across the product lifecycle.
• Develop control strategies for starting material, drug substance and product specifications.
• Review regulatory filings and respond to health authority questions.
• Ensure inspection readiness and participation in audits.
• Communicate complex quality information clearly to leadership and regulators.

Skills

cGMP knowledge

Regulatory knowledge

Cross-functional teamwork

Analytical skills

Communication skills

Problem-solving

Independent work

Education

Bachelor's degree in science or related fields

MS/PharmD/PhD

Job description

Gilead Sciences Inc. is seeking a seasoned Quality leader to drive product quality strategy across development, manufacturing, and regulatory teams. You will lead cross-functional PQT activities, apply risk-based evaluation, and ensure compliant data and processes.

The role focuses on enabling successful regulatory filings, managing inspections (PAI/PLI), and ensuring inspection readiness while balancing quality with business needs.