Head of Analytical Quality Assurance

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

Benefits offered by this job

Medical insurance

401(k) plan

Bonus eligibility

Job summary

Gilead Sciences, Inc. in Foster City, CA is seeking a senior leader to oversee analytical quality for external QC labs and stability programs. You will ensure compliance with cGMP and regulatory requirements, review critical quality documents, and drive CAPA efforts.

The role leads the Analytical Quality Assurance team, partnering with Manufacturing and external partners to support lifecycle priorities and regulatory readiness.

Qualifications

• Bachelor's or higher in chemistry or a related field.
• 12+ years in pharmaceutical quality/QA with progressive leadership.
• Experience with GMP/cGMP, ICH, FDA/EMA regulatory expectations.
• Proven ability to review data, investigations and risk-based decisions.

Responsibilities

• Lead analytical quality oversight for external QC labs and stability programs.
• Review and approve quality documents (SOPs, specs, methods, reports, CAPAs).
• Ensure analytical testing complies with regulatory requirements (FDA/EMA, cGMP).
• Oversee investigations related to OOS/OOT and CAPA recommendations.
• Provide quality governance for contract partners and testing labs.
• Maintain and improve CAPA, change control, risk management, and QA systems.
• Manage audits/inspections and internal QA processes.
• Review NDA/CMC filings' analytical data with cross-functional teams.
• Lead and develop the Analytical Quality Assurance team.

Skills

Quality oversight

Leadership

Regulatory knowledge

Analytical quality

Communication

Education

BS in chemistry

MS in chemistry

PhD in chemistry

Tools

LIMS

SOP software

Job description

Gilead Sciences, Inc. in Foster City, CA is seeking a senior leader to oversee analytical quality for external QC labs and stability programs. You will ensure compliance with cGMP and regulatory requirements, review critical quality documents, and drive CAPA efforts.

The role leads the Analytical Quality Assurance team, partnering with Manufacturing and external partners to support lifecycle priorities and regulatory readiness.