Associate Director, Regulatory Data Quality

Gilead Sciences • Foster City, CA

1d • $182,070 - $235,620

About The Position

The Associate Director, Regulatory Data Quality implements and operationalizes data quality stewardship capabilities across Regulatory Affairs, translating data governance strategies, standards, and frameworks into practical ways of working that improve regulatory data quality, integrity, consistency, and usability. The role embeds accountability for regulatory data, ensures compliance with global regulatory data requirements, and promotes good data management practices throughout the organization.

This position focuses on data stewardship, data quality monitoring and remediation, governance processes, metrics, and continuous improvement. It works across Regulatory Affairs and with patient safety, quality, regulatory CMC, commercial, clinical, development organizations, and enterprise data teams to align governance across end-to-end regulatory processes. The role leads efforts to establish authoritative datasets and leverage innovative technologies, and is part of the Innovation, Digital and External Partnerships (IDEP) Regulatory Affairs Data Governance Team.

As a people leader, the incumbent is expected to foster inclusion, develop employees’ skills and potential, and empower teams by aligning goals and removing barriers.

Requirements

• BA/BS in Life Sciences, Information Management, Regulatory Affairs, or a related field with 10 or more years of relevant experience; or MA/MS with 8 or more years; or PharmD/PhD with 5 or more years.
• Experience in the life sciences or biotech industry.
• Extensive experience leading data governance and stewardship capabilities in a regulated environment.
• Strong experience with regulatory information and its 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 high-complexity, large-scale, cross-functional global change initiatives in Regulatory Affairs.
• Strong track record of cultivating and maintaining strategic relationships and collaborations internally and externally.
• Strong knowledge of the biopharma industry, including regulatory affairs and adjacent business functions.
• In-depth knowledge of systems, tools, metrics, and digital technologies supporting Regulatory Affairs and broader data governance, such as Veeva, Docubridge, Collibra, and Informatica.
• Strong understanding of global regulatory requirements, including FDA, EMA, and ICH requirements.
• Knowledge of data privacy regulations such as GDPR and HIPAA and their implications for regulatory data management.
• Ability to rapidly become acquainted 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.
• Ability to distill complex matters into a clear business case and execution roadmap.
• Ability to align leaders and gain their commitment and engagement for cross-functional strategies, plans, and objectives.
• Advanced meeting facilitation, organizational, and communication skills.
• Strong negotiation and conflict-resolution skills.

Nice To Haves

• Certifications in PMP, change management, or Six Sigma/Lean.
• Ability to travel when needed.

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 effective, integrated, cross-functional data governance framework across organizational boundaries.
• Partner with a matrixed team of representatives from data domains across the organization.
• 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.
• Steward regulatory data to ensure its quality, completeness, and reliability.
• Ensure regulatory data complies with 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, data governance priorities, and objectives.
• Provide guidance to 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 the effectiveness of data governance initiatives.
• Generate reports for senior management and functional leadership on the state of regulatory data as needed.
• Create an inclusive team environment and embed the value of diverse teams in management practices.
• Develop employees through coaching, feedback, and support for their current performance and future potential.
• Empower teams by aligning goals with organizational objectives, holding teams accountable, removing barriers, and connecting them to the broader organization.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
• 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