Director, Quality Assurance Compliance (Global Supplier Quality)

• Establish global visibility and oversight of supplier-related material quality performance, risks, issues, and emerging trends across the network.
• Connect information across sites, suppliers, materials, investigations, defects, changes, inspection/testing experience, and other quality signals to identify patterns and potential systemic risks.
• Proactively identify material or supplier risks that could affect multiple sites, processes, or products and facilitate timely cross-functional assessment and preventive action.
• Identify recurring material issues and emerging trends and ensure learnings from one site, supplier, or material are considered for broader network applicability.
• Develop and utilize material quality metrics, trending, and risk indicators to enable early identification of potential quality issues and continuous improvement opportunities.
• Support harmonization of material defect definitions and global visibility to recurring material defects.
• Provide network-level oversight and coordination for significant supplier-related material quality issues requiring cross-site assessment, supplier escalation, or broader organizational visibility.

• Provide Supplier Quality expertise related to GMP material requirements, specifications, inspection/testing expectations, supplier controls, and material acceptance requirements.
• Partner with Material Technical, Internal Quality, QC, Manufacturing, and other subject matter experts to support appropriate alignment of material requirements to manage supplier or network quality risks.
• Provide the Supplier Quality perspective during new material introduction, material lifecycle activities, specification changes, supplier changes, compendial updates, regulatory changes, audit requests and other activities with potential impact to material quality.
• Apply Quality Risk Management principles to identify opportunities for preventive supplier engagement, risk mitigation, and continuous improvement.
• Support risk-based material qualification, inspection, testing, and control strategies where knowledge of supplier processes, controls, audit history, and performance is relevant.
• Identify opportunities to leverage supplier best practices or material improvements across similar materials, suppliers, or sites to strengthen network performance.

• Serve as a Global Supplier Quality primary contact for significant material quality issues requiring supplier engagement, global visibility, or cross-site coordination.
• Partner with Supplier Quality Leads and Internal Site Quality on material issues requiring formal supplier investigations, CAPAs, supplier performance management, or improvement initiatives.
• Facilitate timely supplier engagement and escalation while ensuring material quality learnings are translated into preventive actions where appropriate.
• Provide material quality insights to Supplier Relationship Management and other supplier performance and governance forums.
• Establish effective partnerships with Internal Quality, Material Technical, QC, Manufacturing, Technical Operations, Procurement/Sourcing, Regulatory, and other relevant stakeholders.
• Support development and continuous improvement of global governance, decision rights, escalation pathways, and RACI for supplier-related material quality activities.
• Represent Global Supplier Quality in applicable material governance forums, audits, regulatory inspections, and cross-functional initiatives.

• Bachelor's degree in Chemistry, Biology, Biochemistry, Engineering, Pharmaceutical Sciences, Materials Science, or related scientific or technical discipline.
• Significant experience in pharmaceutical, biotechnology, or other regulated GMP manufacturing environments.
• Strong knowledge of GMP materials and material quality requirements, including material specifications, qualification, inspection/testing, supplier controls, change management, investigations, and Quality Risk Management.
• Demonstrated experience working with external suppliers on quality issues, technical/material requirements, supplier performance, and continuous improvement.
• Ability to analyze information across multiple sites, materials, and suppliers to identify trends, emerging risks, and systemic improvement opportunities.
• Experience leading complex, cross-functional quality or technical initiatives across multiple functions or sites.
• Strong understanding of GMP quality systems and applicable regulatory requirements.
• Demonstrated ability to influence, facilitate decisions, and communicate effectively across technical, quality, operational, and leadership organizations.

• Experience with materials used in biologics, parenteral, and/or oral solid dose manufacturing, i.e. media, chemical, excipients, and single uses systems.
• Knowledge of compendial requirements, material specifications, incoming material controls, sampling strategies, supplier certification, and risk-based testing approaches.
• Experience with supplier audits, supplier risk management, regulatory inspections, and supplier performance management.
• Experience with enterprise material or ERP systems such as SAP and material lifecycle management systems.

The salary range for this position is: $210,375.00 - $272,250.00. 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*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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

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