Director, Quality

Benefits

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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, Product Quality Complaints Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases. Working in QA at Gilead: Quality Assurance delivers on Gilead's commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are committed to the successful delivery of safe life changing therapies. Job Summary: The Director, Product Quality Complaints is responsible for leading the global product quality complaints program and serving as the Global Process Owner (GPO) for the end-to-end complaints process across the enterprise. This role ensures complaint handling processes are compliant, efficient, risk-based, inspection-ready, and consistently executed across clinical and commercial products, markets, and manufacturing networks.The incumbent provides strategic and operational leadership for complaint intake, triage, investigation oversight, trend monitoring, escalation, reporting, and associated quality system governance. As Global Process Owner, this leader is accountable for the design, standardization, performance, continuous improvement, and global harmonization of the complaints process, including related procedures, training strategy, metrics, roles/responsibilities, and enabling digital systems. This role can be based out the Gilead Foster City, CA site or our Parsippany, NJ site. This role partners closely with cross-functional stakeholders across Quality Assurance, Manufacturing , Patient Safety, Patient Access Solutions, Medical Information, and the wider PQM Quality organization to ensure timely, scientifically sound, and compliant complaint management that protects patients, customers, products, and the company. Job Functions: Lead the global quality complaints function, ensuring compliant intake, evaluation, documentation, investigation oversight, closure, and escalation of product quality complaints. Ensure complaints are managed in accordance with applicable global regulations, company quality standards, and internal procedures (e.g., 21 CFR 211.198, EU GMP Chapter 8, ICH Q10, 21 CFR 820.198, 803 (MDR), and EU MDR/IVDR vigilance requirements) Oversee complaint categorization, prioritization, and routing to ensure timely and appropriate action. Ensure product quality complaints are assessed for potential safety, regulatory reporting, recall, field action, and manufacturing investigation implications. Support regulatory reporting decisions, including Field Alert Reports (FARs), Biological Product. Drive robust complaint trending and signal detection to identify recurring issues, emerging risks, and systemic quality concerns. Serve as the Global Process Owner for the end-to-end complaints process, accountable for process design, governance, standardization, and performance across the enterprise. Establish and maintain the global com

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