Analytical Quality Assurance Director

Biopharma Careers; 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., headquartered in Foster City, CA, seeks a senior leader to oversee analytical quality operations and ensure compliance across external QC testing laboratories and internal methods. The role emphasizes governance, investigations, CAPAs, and cross-functional collaboration to support product lifecycle and regulatory priorities.

The successful candidate will manage an Analytical Quality Assurance team, drive quality culture, and partner with Manufacturing and external partners

Qualifications

• Experience in pharmaceutical quality, analytical sciences, Quality Control or Quality Assurance.
• Leadership responsibilities in GMP-regulated environments.
• Advanced degree preferred (MS/PhD) in chemistry, microbiology, or related field.

Responsibilities

• Provide quality oversight for contract QC testing laboratory activities, stability programs, analytical method validation, and transfers.
• Review and approve analytical quality documents, including SOPs, specifications, methods, change controls, protocols, reports, investigations, deviations, CAPAs, and quality assessments.
• Ensure analytical testing activities comply with cGMP, GLP, ICH, FDA, EMA and other regulatory requirements.
• Oversee investigations related to OOS, OOT, deviations, and laboratory incidents with timely, scientifically sound CAPA recommendations.
• Provide quality oversight for contract partners and testing laboratories, including qualification, performance monitoring, audits, quality agreements, and documentation resolution.

Skills

Quality Oversight

Cross-functional collaboration

Regulatory knowledge

Leadership

Analytical data evaluation

Education

BS in chemistry/microbiology

MS in chemistry/microbiology

PhD in chemistry/microbiology

Job description

Gilead Sciences, Inc., headquartered in Foster City, CA, seeks a senior leader to oversee analytical quality operations and ensure compliance across external QC testing laboratories and internal methods. The role emphasizes governance, investigations, CAPAs, and cross-functional collaboration to support product lifecycle and regulatory priorities.

The successful candidate will manage an Analytical Quality Assurance team, drive quality culture, and partner with Manufacturing and external partners