Director, Quality Control - Laboratory Investigations

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   Scope of Accountability   1. Global Process Ownership & Governance Serve as the global decision‑making authority for the Laboratory Investigations process, including scope, interpretation, and execution expectations. Own and maintain the global standard and SOPs governing laboratory investigations, ensuring alignment across all QC laboratories. Define process governance, escalation pathways, and decision rights in alignment with QSE principles. Ensure all global laboratory investigations standards, procedures, and processes meet evolving regulatory expectations and reflect current cGMP, ICH, and industry best practices. Monitor the external regulatory and industry environment for emerging trends, enforcement patterns, and new or revised guidance impacting laboratory investigations, and proactively translate insights into global standards and strategy. Own enterprise‑level risk identification, assessment, and mitigation for the laboratory investigations process; escalate and manage compliance and quality risks through defined governance mechanisms. Lead alignment and integration with other global quality processes and Global Quality Business Process Owners across the Pharmaceutical Quality System (PQS), ensuring cohesive end‑to‑end quality execution. 2. Process Design, Documentation & Harmonization Own and continuously evolve the end‑to‑end laboratory investigations lifecycle from detection through closure and effectiveness verification. Establish global interpretation of investigation requirements, enabling consistent application across sites, modalities, and product portfolios. Drive enterprise‑wide standardization, simplification, and scalability of laboratory investigation practices while enabling appropriate risk‑based flexibility. 3. System Enablement & Digital Workflow Act as global process owner for laboratory investigation records captured in the GVault Quality Management System (QMS). Define strategic business requirements and partner with IT/QMS teams on: Laboratory Investigation Record (LIR) workflows Integration with deviations and issue escalation processes Enterprise‑level data visibility, analytics, and reporting. Represent the business as the accountable authority in system design decisions affecting internal and external LIR workflows. Govern business requirements and business‑as‑usual (BAU) processes for laboratory investigation supporting Quality IT systems in partnership with IT system owners. Ensure supporting Quality IT systems meet regulatory, data integrity, and GxP requirements. Approve system changes and the release of new or revised system functionality into the production environment in alignment with global process and compliance expectations.   4. Cross‑Functional & Network Leadership Provide strategic leadership to the Global Laboratory Investigation Network, providing a forum for alignment, feedback, and continuous improvement across QC sites. Serve as a senior partner to: QC site leadership and laboratory management Quality Systems, Compliance, and Inspection Readiness leaders Stability, Method Lifecycle, and Reference Standards process owners Set and reinforce consistent enterprise expectations for investigation quality, scientific rigor, and documentation. Act as a recognized subject matter authority, coach, and communicator of expectations to sites and stakeholders. Build and sustain strong stakeholder relationships, proactively seeking and incorporating feedback to enhance global process effectiveness. Facilitate the sharing, adoption, and scaling of good practices, learnings, and innovations across the global laboratory network.   5. Inspection Readiness & Compliance Ensure the laboratory investigations process remains compliant with global regulatory expectations, including FDA and international guidance for OOS investigations. Support audit and inspection readiness by: Defining global expectations for investigation documentation quality Ensuring consistency in root cause analysis and scientific justification Serve as the accountable process owner and senior spokesperson during regulatory inspections and internal audits related to laboratory investigations. Act as the accountable owner for inspection defense related to the laboratory investigations program, including ownership of inspection observations, response strategies, and sustained compliance with cGMP and ICH expectations.   6. Metrics, Trending & Continuous Improvement Define, own, and govern enterprise‑level KPIs and performance indicators for laboratory investigations, such as: Investigation cycle time Recurrence and systemic trending of assignable causes Quality, consistency, and timeliness of investigation closures Leverage global investigation data to identify systemic risks, capabilities gaps, and improvement opportunities across QC laboratories. Drive continuous improvement initiatives aligned with QSE goals and enterprise quality objectives. Actively monitor signals and indicators of process performance, including internal and external audit observations, deviations, complaints, issue management data, and adverse trends. Create and direct global improvement strategies, initiatives, and plans to enhance compliance, efficiency, and effectiveness of laboratory investigations. Apply Lean principles and champion adoption of advanced analytics, automation, and emerging technologies to enhance investigation effectiveness and efficiency. Lead or sponsor global programs or initiatives as required to deliver Quality transformation and enterprise Quality strategy.   7. Training, Capability & Knowledge Enablement Establish global training frameworks, certification expectations, and knowledge assets supporting consistent, high‑quality laboratory investigations. Monitor adherence to global standards and intervene strategically through targeted remediation, coaching, and capability development where gaps are identified.     Qualifications Required Bachelor’s degree in chemistry, Life Sciences, or related discipline. 12+ years in Quality Control, Analytical Development, Stability, or Quality Systems within regulated environments. Demonstrated success operating at a strategic, enterprise level with global accountability. Demonstrated mastery of GMP laboratory investigations, including OOS/OOT handling and root cause analysis. Experience leading global analytical, QC, or other quality networks/projects. Preferred Direct experience performing analytical testing in a QC or other regulated environment. Proven experience as a Global Business Process Owner or enterprise process governance leader. Experience with electronic Laboratory and QMS platforms (e.g., GVault QMS, LIMS, ELN). Direct involvement in global SOP strategy, regulatory inspections, and inspection support.   Key Competencies Process Ownership & Accountability – clear decision‑making authority and ownership mindset. Scientific & Analytical Rigor – strong understanding of analytical testing and investigation principles. Influence Without Authority – ability to align global stakeholders across sites and functions. Quality & Compliance Mindset – proactive focus on inspection readiness and regulatory expectations. Change Leadership – ability to drive global adoption of standardized, scalable processes.   For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.