Regulatory Data Quality Leader - Global Governance

Gilead Sciences Inc.; Foster City (CA); On-site; USD 182,000 - 236,000; Full time

Benefits offered by this job

Medical, dental, vision, and life保险

Paid time off

Discretionary annual bonus

Stock-based long-term incentives

Job summary

Gilead Sciences Inc. in Foster City, CA, seeks a senior leader to implement regulatory data quality and governance across Regulatory Affairs.

You will translate governance strategies into practical methods, ensuring data integrity, compliance, and cross‑functional collaboration with development and quality teams. The role focuses on data stewardship, quality monitoring, governance processes and KPIs to drive continual improvement in regulatory data management and readiness for regulatory

Qualifications

• BA/BS in Life Sciences, Information Management, Regulatory Affairs, or related field with 10+ years’ relevant experience.
• MA/MS with 8+ years’ relevant experience.
• PharmD/PhD with 5+ years’ relevant experience.
• Extensive experience leading data governance and stewardship in regulated environments.
• Knowledge of global regulatory requirements (FDA, EMA, ICH) and data privacy regulations (GDPR, HIPAA).

Responsibilities

• Operationalize the Regulatory Affairs Data Stewardship framework, standards and operating model across regulatory functions and data domains.
• Support the Regulatory Affairs Data Governance Council and drive data integrity and quality across the organization.
• Develop and implement a comprehensive data governance framework for Regulatory Affairs data and processes.
• Lead cross‑functional data governance initiatives spanning organizational boundaries.
• Collaborate with data owners to document definitions, standards, ownership and data quality requirements.
• Align Regulatory Affairs data standards with enterprise data initiatives.
• Act as a steward for regulatory data ensuring quality, completeness and reliability.
• Ensure regulatory data complies with FDA/EMA/global requirements and inspection readiness.

Skills

Data governance

Regulatory data

Cross-functional collaboration

Communication skills

Strategic thinking

Education

BA/BS in Life Sciences/Info Mgmt/Regulatory Affairs

MA/MS with 8+ years

PharmD/PhD with 5+ years

Tools

Veeva

Docubridge

Collibra

Informatica

Job description

Gilead Sciences Inc. in Foster City, CA, seeks a senior leader to implement regulatory data quality and governance across Regulatory Affairs.

You will translate governance strategies into practical methods, ensuring data integrity, compliance, and cross‑functional collaboration with development and quality teams. The role focuses on data stewardship, quality monitoring, governance processes and KPIs to drive continual improvement in regulatory data management and readiness for regulatory