Associate Director, Supplier Quality

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.

• Provide supplier quality oversight of material suppliers (e.g., media, chemicals & excipients, single use systems, primary & secondary packaging component, device) under a centralized SQM function
• Manage suppliers holistically by utilizing internal (e.g., deviation trends, OOS) and external signals (e.g., regulatory intelligence, external audits)
• Manage supplier change notifications or vendor-initiated changes
• Manage supplier investigations and corrective actions
• Manage completion of audit observation responses in a timely and effective manner
• Align and negotiate Quality Agreement terms with internal stakeholders and external partners
• Deploy quality risk management principles to ensure appropriate risk mitigation and control is exercised at the commodity/material level when approving supplier corrective actions
• Monitor and measure the effectiveness of suppliers and provide periodic updates to Senior Leadership
• Develop and implement processes for supplier management and material management lifecycles
• Manage master data in SAP for supplier information to ensure alignment globally
• Travel may be required up to 20%
• Other responsibilities as required to meet business needs

• 10+ years of relevant experience in a GMP environment along with a bachelor’s degree in science/engineering (OR)
• 8+ years of relevant experience and a master’s degree in science/ engineering
• Prior people management experience preferred

• Experience with direct supplier oversight and proficiency at the commodity/material level
• Knowledge of filling operations, packaging operations and related issues
• Knowledge of incoming inspection processes including material inspection plans, certification of materials and AQLs
• Knowledge and working experience in some of the following areas:
  • Single use systems (extractables and leachables, leakage defects)
  • Syringes (glass breakage investigations/certifications, fractography)
  • Needles (defect investigations, e.g., hooked, bent, and cracked needles)
  • Vials (delamination issues, cracked vials, developing reinspection processes, understanding of manufacturing processes)
  • Stoppers (knowledge of coring, particulate investigations)
  • Devices (manual needle guard issue resolution, auto-injector issues, component manufacturing)
• FDA inspection presenter experience
• Working experience in managing strategic partners and relationships
• In addition to QA experience, background in process or technical development, or manufacturing
• Demonstrated leadership skills and ability to make critical decisions related to projects and tasks
• Experience with applying risk management principles while providing supplier quality oversight
• Strong relationship management skills including ability to adapt communication style and content to suit audience and stakeholder needs
• Candidate must be self-driven and work well in a team, taking on different roles as needed
• Candidate must be able to prioritize tasks and drive toward solutions, while working in a fast-paced and changing environment

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.