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Director, Quality Assurance Compliance… at Gilead Sciences · United…
Job Description
Director, Quality Assurance Compliance (Global Supplier Quality)
Location: United States - California - Foster City · Onsite - Hybrid Eligible
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Director, Global Supplier Quality – Material Quality Network Oversight
Position Summary
The Director, Global Supplier Quality will focus on network oversight for material quality and is responsible for providing proactive, network-level Supplier Quality oversight of GMP materials across the Gilead network.
The primary purpose of this role is to anticipate and prevent material quality issues by connecting information across sites, materials, suppliers, quality systems, and emerging requirements. This role will establish global visibility to material quality signals and trends, identify emerging or systemic risks, and facilitate preventive actions with suppliers and internal stakeholders to mitigate issues recurrence or expansion across the network.
As a newly established role supporting the Global Supplier Quality future-state plan, the Director will help define and mature Global Supplier Quality responsibilities for connecting material quality, supplier capability, quality risk, and supply risk across the network. The role will ensure that learnings and emerging risks identified at one site are proactively evaluated for broader impact across sites, material categories, and approved suppliers. Through clear cross-functional interfaces, governance, decision rights, and escalation pathways, the Director will connect the dots across the network to drive proactive supplier engagement, risk mitigation, and continuous improvement.
Key Responsibilities
Proactive Material Quality Network Oversight
- 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.
Material Requirements, Supplier Capability & Prevention
- 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.
Supplier Escalation, Governance & Cross-Functional Leadership
- 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.
Role Scope and Interfaces
This role provides the Global Supplier Quality network perspective for material quality and is not intended to replace or duplicate functional and site responsibilities. Technical ownership, product and site quality decisions, material specification, qualification, inspection, disposition, and other functional accountabilities remain with the designated accountable organizations in accordance with established governance and decision rights.
Qualifications
Required
- 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.
Preferred
- 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.
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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