Director, Analytical Quality Assurance — Global QC Leader

Gilead Sciences Inc.; Maryland; On-site; USD 210,000 - 272,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Paid time off

Medical, dental, vision, and life保险

Job summary

Gilead Sciences, Inc. seeks a senior analytical quality leader to oversee external QC testing laboratories, stability programs, and analytical method transfers, ensuring scientifically sound, risk-based decisions.

You will govern contracts with external partners, collaborate across Manufacturing and regulatory teams, and lead the Analytical Quality Assurance group to foster accountability and a culture of quality.

Qualifications

• Experience in pharmaceutical quality, analytical sciences, Quality Control, Quality Assurance, or GMP-regulated environment.
• 12+ years of relevant experience with a BS/BA; 10+ with MS; 8+ with PhD
• Strong leadership to coach and develop high-performing teams and drive continuous improvement.

Responsibilities

• Provide analytical quality oversight for contract QC testing laboratories and stability programs.
• Review and approve analytical quality documents (SOPs, specifications, methods, change controls, protocols, reports, investigations, deviations, CAPAs).
• Ensure compliance with cGMP, GLP, ICH, FDA, EMA and other regulatory requirements.
• Oversee investigations related to OOS/OOT and laboratory incidents with timely, scientifically sound resolutions and CAPA recommendations.
• Provide quality governance for contract partners and testing laboratories, including audits and quality agreements.

Skills

Analytical quality oversight

Quality governance

Cross-functional collaboration

Strong communication

Leadership

Problem-solving

Education

Bachelor's degree in chemistry/microbiology or related field

MS or PhD preferred

Job description

Gilead Sciences, Inc. seeks a senior analytical quality leader to oversee external QC testing laboratories, stability programs, and analytical method transfers, ensuring scientifically sound, risk-based decisions.

You will govern contracts with external partners, collaborate across Manufacturing and regulatory teams, and lead the Analytical Quality Assurance group to foster accountability and a culture of quality.