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

Gilead Sciences • Foster City, CA

2d

About The Position

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.

Requirements

• Bachelor’s degree and/or substantial relevant experience with 14+ years in pharmaceutical quality, manufacturing, engineering, or a related scientific discipline.
• Experience working cross‑functionally and cross‑culturally across the supply chain in a regulated environment.
• Demonstrated ability to influence and define global ways of working in complex, matrixed organizations.
• Strong risk‑based decision‑making 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 cross‑functional customers.
• Independence and ability to work with minimal supervision; strong planning, prioritization, and follow‑through.
• Subject matter expertise in Human & Organizational Performance (HOP) and Human Dependent Process Improvement (HDPI) and their proactive application.

Nice To Haves

• Experience leading transformational change programs and capability‑building 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 decision‑making approaches.

Responsibilities

• 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.
• 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.
• Build capability within regions to apply HOP/HDPI and systems‑model 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 error‑likely 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 in‑person support (e.g., workshops, Gemba, coaching) to accelerate adoption and competency at manufacturing sites.
• Develop and maintain global training curricula, certification requirements, and practical job aids for HOP/HDPI methods and proactive tools.
• Deliver and oversee train‑the‑trainer 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 error‑proofing to improve user experience and reduce manual burden.
• 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.
• 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 influence‑based leadership across the network.
• Enterprise‑wide accountability spanning all global markets and operating regions.
• Regular engagement across multiple countries and cultures; expected travel approximately 25–35% (site support, workshops, governance, and external forums).

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees