Sr Director, Proactive Quality Human & Organizational Performance (HOP)

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.

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Job Description

The Senior Director Proactive Human & Organizational Performance (HOP) is a senior global Quality leader responsible for defining governing and deploying proactive quality approaches that strengthen humandependent processes and system reliability across the Pharmaceutical Quality System (PQS) and operations. This role serves as the Global Business Process Owner (BPO) for Proactive HOP accountable for global standards performance management capability building and continuous improvement of the Proactive HOP program.

The role reports directly to the Executive Director of Risk and Proactive Quality and partners closely with other Quality GPOs Local and Functional Process Owners and site leadership teams to embed Human Dependent Process Improvement (HDPI) and systemsmodel thinking into process design control strategies and daily execution. The Senior Director champions learningbased nonpunitive practices that reduce errorprone conditions improve decisionmaking and enable sustained compliance and operational excellence aligned with cGMP and evolving global regulatory expectations.

Key Accountabilities

Global Business Process Ownership and Governance (Proactive HOP)

Serve as Global Business Process Owner (BPO) for Proactive HOP with enterprise accountability for strategy standards performance and continuous improvement.

Design own and approve global standards policies procedures and supporting training/job aids ensuring alignment with cGMP ICH and regulatory expectations across all markets.

Define global KPIs monitor adherence and effectiveness and drive global standardization simplification and sustained adoption through a global process network.

Provide subject matter expert (SME) coaching and consultation to sites/regions on humancentric risk mitigation and humandependent process design.

Actively monitor signals of process performance (e.g. audit/inspection observations issue management deviations complaints and trend data) and escalate/correct systemic risks as required.

Own inspection readiness and defense for the Proactive HOP program including observation responses and sustained remediation where applicable.

Manage interdependencies with other PQS processes/GPOs (e.g. risk management deviations change control training selfinspection) to ensure endtoend integration.

Partner with IT system owners to maintain business requirements for enabling systems; ensure supporting Quality IT solutions meet GxP requirements and approve relevant changes/releases.

Integration and Delivery of Proactive Operations Quality Objectives

Partner with global process owners/GPOs and Local/Functional Process Owners to identify and implement proactive improvements that drive nextlevel performance in humandependent processes (e.g. risk management deviations change control selfinspection training).

Codevelop global and functional/site proactive operations objectives; support sites in defining locally relevant deliverables aligned to global priorities.

Establish governance to track deliverables benefits realization and sustainability of improvements across the network.

Lead and/or sponsor significant continuous improvement initiatives (e.g. HDPI acceleration proactive risk assessment approaches errorproofing and digital enablement) that improve effectiveness and efficiency.

Human & Organizational Performance (HOP) and SystemsModel / HDPI Acceleration

Build capability within regions to apply HOP/HDPI and systemsmodel thinking proactively to quality systems process execution and controls to prevent impactful errors before they occur.

Mentor and coach functional and site teams to modernize control strategies (e.g. focusing on true critical steps and errorlikely conditions vs. treating all steps as equal).

Embed Proactive HOP principles into equipment and process design through partnership with engineering technical and operational stakeholders.

Provide a balanced mix of remote and inperson support (e.g. workshops Gemba coaching) to accelerate adoption and competency at manufacturing sites.

Proactive Tools Training and Community of Practice

Develop and maintain global training curricula certification requirements and practical job aids for HOP/HDPI methods and proactive tools.

Deliver and oversee trainthetrainer models to scale capability through functional/site champions.

Facilitate sharing calibration and adoption of good practices and lessons learned across the network.

Continuously seek user feedback and identify opportunities for simplification automation and errorproofing to improve user experience and reduce manual burden.

Leadership Influence and External Engagement

Lead through influence in a complex matrixed environment aligning stakeholders across sites and functions to deliver sustained proactive quality outcomes.

Monitor external trends (e.g. regulatory expectations industry guidance emerging practices) and translate insights into updates to strategy standards and capability building.

Represent the organization in external industry forums related to HOP and proactive quality building benchmarks and partnerships that advance internal maturity.

Typical People Management Responsibility

Senior leader of a global Proactive HOP process network with matrix accountability across sites and functions.

Direct people management responsibility may include a small expert team and/or program resources (TBD) with broader influencebased leadership across the network.

Global Remit

Enterprisewide accountability spanning all global markets and operating regions.

Regular engagement across multiple countries and cultures; expected travel approximately 2535% (site support workshops governance and external forums).

Education Qualifications Skills and Experience

Essential

Bachelors degree and/or substantial relevant experience with 14 years in pharmaceutical quality manufacturing engineering or a related scientific discipline.

Experience working crossfunctionally and crossculturally across the supply chain in a regulated environment.

Demonstrated ability to influence and define global ways of working in complex matrixed organizations.

Strong riskbased decisionmaking skills and a systems mindset; able to translate insights into practical controls and behaviors.

Excellent communication skills and ability to build relationships across a global network and with crossfunctional customers.

Independence and ability to work with minimal supervision; strong planning prioritization and followthrough.

Subject matter expertise in Human & Organizational Performance (HOP) and Human Dependent Process Improvement (HDPI) and their proactive application.

Desirable

Experience leading transformational change programs and capabilitybuilding at scale.

Understanding and experience in GMP change control and event/deviation management.

Experience with Business Process Management and operating model design; change agent roles.

Project/program management experience including governance planning and benefits realization.

Experience with global GxP IT systems delivery and lifecycle management; digital enablement of quality processes.

Strong business acumen and ability to assess trends/complex data and build robust business cases and impact analyses.

Training and/or certification in Lean Six Sigma or comparable continuous improvement methodologies.

Experience with DAI or similar structured decisionmaking approaches.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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