Director, Quality Assurance Compliance (Global Supplier Quality) — United States - California - Foster City

Gilead · United States - California - Foster City

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This Director, Quality Assurance Compliance (Global Supplier Quality) role at Gilead was posted in the last 5 days. Before applying, run your resume through the checker on the right — most rejections here are keyword and formatting mismatches, not qualifications.

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.   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. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com  for assistance. For more information about equal employment opportunity protections, please view the  'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.   Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

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