Director, Quality Control Laboratory Investigations

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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 decisionmaking 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 enterpriselevel 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 endtoend quality execution.
  

2. Process Design Documentation & Harmonization

• Own and continuously evolve the endtoend 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 enterprisewide standardization simplification and scalability of laboratory investigation practices while enabling appropriate riskbased 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

• Enterpriselevel 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 businessasusual (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. CrossFunctional & 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 enterpriselevel 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 highquality laboratory investigations.

• Monitor adherence to global standards and intervene strategically through targeted remediation coaching and capability development where gaps are identified.

Qualifications

Required

• Bachelors 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 decisionmaking 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.

Required Experience:

Director

Employment Type : Full-Time
Experience: years
Vacancy: 1