Director, Quality Assurance Compliance

Gilead Sciences•Foster City, CA

2d•$210,375 - $272,250

About The Position

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 Management Program Position Impact The Director, Global Supplier Quality Management Program serves as the Global Process Owner (GPO) for Supplier Quality Management, providing enterprise leadership and subject matter expertise for the strategy, governance, processes, systems, quality documents, and metrics of the supplier quality program across the end-to-end supplier lifecycle. This role is accountable for building and advancing a globally harmonized, risk-based, and customer-focused supplier quality program in partnership with internal quality functions at Gilead sites that strengthens stakeholder partnerships, drives consistent and scalable ways of working, and enhances quality, compliance, supply continuity, and operational performance across the global network. Through collaborative leadership, deep process expertise, digital innovation, and data-driven decision making, the Director advances supplier quality capabilities and operating models that enable scalable business growth, operational excellence, supply continuity, and regulatory compliance.

Requirements

Bachelor's degree in Life Sciences, Engineering, Quality, Supply Chain, or related field.
10+ years of progressive experience in Supplier Quality Management
5+ years of global process ownership experience, leadership and influencing outcomes for global quality programs.
Extensive knowledge of pharmaceutical, biotechnology, medical device, or regulated industry requirements.
Demonstrated experience leading complex global change initiatives, business process transformations, and cross-functional program implementations in a matrixed organization.
Strong understanding of supplier quality systems, risk management, supplier oversight, and quality management principles.
Experience facilitating executive-level governance forums, building stakeholder consensus, and influencing strategic decisions across multiple functional areas.
Experience developing, leading and presenting on enterprise strategies, governance frameworks, and performance measurement systems.
Proven ability to influence senior leaders and drive cross-functional alignment in a matrix environment.

Nice To Haves

Advanced degree (MS, MBA, or equivalent) preferred.
Experience with Lean concepts, and Lean Six Sigma Green Belt (+) is desired.

Responsibilities

Serve as the Global Process Owner (GPO) for Supplier Quality Management across the end-to-end supplier lifecycle.
Steward and decision authority for global supplier quality processes, standards, and governance models, ensuring consistent interpretation and implementation across the enterprise considering proactive issue and risk mitigation for all integrated program stakeholders.
Own and execute the plan and evolution roadmap for the Supplier Quality Management Program, aligning program capabilities with business objectives, regulatory expectations, and future-state operational needs with stakeholders representing all supplier type categories.
Lead future-state process design initiatives by translating strategic objectives, stakeholder needs, regulatory requirements, and industry best practices into scalable supplier quality solutions.
Establish and maintain enterprise-wide supplier quality standards, governance, policies, procedures, and business processes.
Ensure a globally aligned, scalable, risk-based, and customer-focused framework that delivers consistent quality oversight and ways of working across the enterprise.
Enable and champion cross-functional collaboration and continuous improvement, partnering with integrated program stakeholders at Gilead manufacturing sites and within global functions to understand operational needs, remove process barriers, and lead the transformation and alignment of local supplier quality practices within the global Supplier Quality Management framework.
Provide global oversight and governance for supplier quality processes, including but not limited to: Supplier onboarding, qualification, periodic evaluation, monitoring, and offboarding; Supplier risk management and performance management; Supplier change management; Supplier deviations, investigations, and issue management; Supplier escalation processes; Supplier corrective and preventive action (CAPA) management.
Lead cross-functional teams and governance bodies responsible for the design, review, approval, implementation, and continuous improvement of global supplier quality processes, capabilities, and solutions.
Build alignment among diverse stakeholders by facilitating decisions, resolving conflicts, and driving enterprise adoption of program changes across sites, functions, and business units.
Champion transformation initiatives that improve effectiveness, efficiency, scalability, and user experience.
Facilitate workshops, business process assessments, and cross-functional working sessions to identify opportunities, define requirements, and design improved supplier quality capabilities.
Lead comprehensive change management strategies that drive stakeholder alignment, organizational readiness, process adoption, capability development, and sustainable implementation of global program changes.
Establish proactive approaches to identify, assess, and mitigate supplier quality, compliance, supply continuity, and operational risks.
Ensure supplier quality processes remain compliant with global regulatory requirements and inspection-ready expectations.
Drive risk-based oversight models that enable effective prioritization of resources and quality activities.
Monitor emerging risks, industry trends, and regulatory expectations to strengthen program effectiveness.
Build cohesive partnerships across sphere of influence in Global Quality, Manufacturing, Supply Chain, Procurement, Technical Operations, Regulatory Affairs, Information Technology, and other key stakeholders to drive alignment and program success.
Establish governance structures that promote collaboration, transparency, accountability, and effective decision-making.
Strengthen stakeholder alignment through shared ownership of supplier quality objectives, performance, and outcomes.
Facilitate cross-functional governance forums to resolve complex issues, manage risks, and drive strategic program decisions.
Support alignment and integration with related programs, including Supplier Change Notification Assessment (SNA) and broader External Quality initiatives.
Establish supplier quality performance measures, reporting frameworks, dashboards, and key performance indicators.
Enable data-driven decision making through meaningful analytics, performance insights, and business intelligence tools.
Partner with Information Technology, Quality Systems, and Digital teams to implement and sustain enabling technologies and quality system infrastructure.
Advance the use of automation, analytics, artificial intelligence, and predictive quality methodologies to enhance supplier oversight and risk management.
Drive continuous improvement through benchmarking, performance monitoring, and adoption of industry-leading practices.
Support SAP GxP Supplier process definition, data governance, and maintenance.