Associate Director, Deviation & CAPA Management - job 2 of 2

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

• Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• Writes and/or implements changes to Standard Operating Procedures.
• Implements and maintains systems, programs, and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs), along with compliance of protocols and safety regulations.
• Maintains programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency guidelines.
• May interface with regulatory agencies as required.
• Works directly with operating entities, responsible for ensuring that audits of quality systems are conducted on a continuing basis, to enforce requirements and meet specifications.
• Leads compliance audits as required.
• Responsible for investigation management of critical, major, and minor investigations related to GxP operations.
• Oversees metrics, trending, and reporting of relevant quality system records (i.e. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental targets.
• Supports management review process through development, generation, and review of quality system metrics and trending, and escalate issues as required.
• Drive maintenance and improvement to quality systems processes.
• Partner with operating entities and internal clients to ensure resolution of quality issues.
• Lead the development of training programs regarding investigation, deviation, and CAPA systems.

• Bachelors Degree and 10+ years of experience required OR
• Masters Degree and 8+ years of experience required OR
• PhD and 2+ years of post-doc experience required

The salary range for this position is: $172,890.00 - $223,740.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.