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

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
 

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 human‑dependent 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 systems‑model thinking into process design, control strategies, and daily execution. The Senior Director champions learning‑based, non‑punitive practices that reduce error‑prone conditions, improve decision‑making, 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 human‑centric risk mitigation and human‑dependent 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, self‑inspection) to ensure end‑to‑end 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 next‑level performance in human‑dependent processes (e.g., risk management, deviations, change control, self‑inspection, training).

·       Co‑develop 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, error‑proofing, and digital enablement) that improve effectiveness and efficiency.

Human & Orga