Global QC Leader - Strategy, Tech & Compliance

Regulatory Jobs; La Verne (CA); On-site; USD 221,000 - 286,000; Full time

Benefits offered by this job

Medical benefits

Life insurance

Job summary

Gilead Sciences Inc. is seeking a senior Quality Control leader to head QC at our site, overseeing analytical, microbiology, materials, in-process, and product QC programs for small molecules and biologics.

You will define the site QC strategy, ensure regulatory readiness, support PPQ and tech transfers, and drive Lean Laboratory practices to improve efficiency while maintaining data integrity and GMP compliance.

Qualifications

• Bachelor’s degree in a scientific discipline with 14+ years in pharma or biopharma, leadership in QC within GMP.
• Masters or PhD with 12+ years in pharma or biopharma, leadership in QC within GMP.
• Recognized technical leader with deep expertise in analytical sciences and QC across small molecules and biologics.

Responsibilities

• Lead and oversee all Quality Control functions at the site, including analytical, microbiology, raw materials, in-process, drug substance, drug product, and stability programs across small molecule and biologics platforms.
• Define and execute the site QC strategy, aligned with global quality and business objectives.
• Ensure effective support of commercial manufacturing, PPQ, technical transfers, and new product introduction.
• Ensure QC operations meet global GMP requirements and maintain a continuous state of inspection readiness.
• Represent QC during regulatory inspections and audits, ensuring strong compliance and data integrity standards.
• Contribute to and lead QC network harmonization and global initiatives, ensuring alignment with enterprise standards and practices.

Skills

QC Strategy

Regulatory Inspections

People Leadership

Analytical Sciences

GMP Compliance

Cross-functional Leadership

Data Integrity (ALCOA+)

Lean Laboratory

Education

Bachelor's degree in science

Master's degree in science

PhD in a scientific discipline

Job description

Gilead Sciences Inc. is seeking a senior Quality Control leader to head QC at our site, overseeing analytical, microbiology, materials, in-process, and product QC programs for small molecules and biologics.

You will define the site QC strategy, ensure regulatory readiness, support PPQ and tech transfers, and drive Lean Laboratory practices to improve efficiency while maintaining data integrity and GMP compliance.