Associate Director, Regulatory Data Quality

Gilead Sciences • Foster City, CA

2d

About The Position

The Associate Director, Regulatory Data Quality will implement and operationalize data quality stewardship capabilities across Regulatory Affairs. The role translates data governance strategies, standards, and frameworks into practical working practices that improve the quality, integrity, consistency, and usability of regulatory data. It ensures that data integrity and quality expectations are embedded in organizational practices and that regulatory data meets global compliance requirements.

The position focuses on data stewardship, data quality monitoring and remediation, governance processes, metrics, and continuous improvement. It establishes accountability for regulatory data and supports adoption of effective data management practices. The role collaborates with patient safety, quality, regulatory CMC, commercial, clinical, and other development organizations on governance activities spanning end-to-end regulatory processes. It also aligns with master data management initiatives across development systems and information technology, and leads efforts to improve data quality through authoritative datasets and innovative technologies.

As a member of the Innovation, Digital and External Partnerships (IDEP) Regulatory Affairs Data Governance Team, the incumbent helps develop and continuously improve global regulatory practices, processes, tools, teams, and capabilities. The role may require travel.

Requirements

• BA/BS in Life Sciences, Information Management, Regulatory Affairs, or a related field and 10+ years of relevant experience; or MA/MS and 8+ years; or PharmD/PhD and 5+ years.
• Experience in the life sciences or biotechnology industry.
• Extensive experience leading data governance and stewardship capabilities in a regulated environment.
• Strong experience with regulatory information domains and their relationship to product development and lifecycle management, including product registrations/licenses, investigational and marketing applications, submission content, label tracking, and variations.
• Significant experience establishing authoritative data assets and developing operating constructs that ensure data integrity and quality.
• A strong track record of working and negotiating across organizations in a matrixed environment.
• Experience leading complex, large-scale, cross-functional global change initiatives in Regulatory Affairs.
• Strong knowledge of the biopharmaceutical industry, Regulatory Affairs, and adjacent business functions.
• In-depth knowledge of systems, tools, metrics, and digital technologies supporting Regulatory Affairs and broader data governance.
• Strong understanding of global regulatory requirements, such as FDA, EMA, and ICH requirements.
• Knowledge of data privacy regulations, such as GDPR and HIPAA, and their implications for regulatory data management.
• Ability to quickly become familiar with Gilead’s current ways of working and data quality approaches.
• Advanced regulatory and business knowledge and analytical ability, including assessing complex multidisciplinary data and advising on regulatory implications.
• Ability to influence across organizational levels and externally in a collaborative manner.
• Strong communication and organizational skills, including the ability to distill complex matters into a clear business case and execution roadmap.
• Ability to align leaders and secure commitment to cross-functional strategies, plans, and objectives.
• Advanced meeting facilitation skills and strong negotiation and conflict-resolution skills.

Nice To Haves

• Certifications in PMP, change management, or Six Sigma/Lean.
• Experience with systems and tools such as Veeva, Docubridge, Collibra, or Informatica.

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 the organization’s approach to data integrity and quality.
• Evolve and implement a comprehensive data governance framework suited to Regulatory Affairs data and processes.
• Drive an integrated, cross-functional data governance framework across organizational boundaries and partner with representatives from data domains.
• Work with regulatory subject matter experts to document business definitions, data standards, ownership, and data quality requirements.
• Align Regulatory Affairs data standards with broader cross-functional and enterprise data initiatives.
• Act as a steward for regulatory data, ensuring its quality, completeness, and reliability.
• Ensure regulatory data adheres to local, regional, and global requirements, including those of the FDA, EMA, and other regulatory bodies.
• Partner with quality and compliance teams to monitor evolving regulatory standards and inspection-readiness expectations and incorporate them into data quality practices.
• Collaborate across Regulatory Affairs and Quality to establish authoritative datasets, governance priorities, and objectives.
• Guide functions on data governance and stewardship best practices.
• Evaluate and implement data quality management tools and technologies to improve operations and data quality.
• Drive digital innovation in data governance activities and approaches.
• Collaborate with development systems and data owners on system upgrades, integrations, and enhancements related to regulatory data integrity and quality.
• Develop and track key performance indicators to measure data governance effectiveness.
• Generate reports for senior management and functional leadership on the state of regulatory data.
• Create inclusion, develop talent, and empower teams in accordance with People Leader accountabilities.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives, depending on role eligibility.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior