Overview In this role you will lead the implementation of data quality stewardship for Regulatory Affairs at Gilead, translating governance strategies into practical practices to ensure data integrity and regulatory compliance. You will partner with cross-functional teams to embed data management as a core capability, enabling trusted regulatory data across global processes. The work spans governance, metrics, and continuous improvement to support impactful regulatory decisions. This is a strategic, cross-organizational role with a strong focus on innovation in data quality. Compensation / Benefitsdiscretionary annual bonusdiscretionary stock-based long-term incentivespaid time offmedical, dental, vision, and life insurancebenefits packageflexible work arrangements ResponsibilitiesOperationalize the Regulatory Affairs Data Stewardship framework across regulatory functions and data domainsSupport the Regulatory Affairs Data Governance Council and drive data integrity initiativesEvolve a comprehensive data governance framework for Regulatory Affairs data and processesAccountable for a cross-functional data governance framework crossing organizational boundariesPartner with data domain representatives and regulatory SMEs to define data standards, ownership, and quality requirementsAlign Regulatory Affairs data standards with enterprise data initiativesAct as steward for regulatory data ensuring quality, completeness and reliabilityEnsure regulatory data complies with FDA, EMA and other regulatory requirementsCollaborate with Quality to stay updated on evolving regulatory standards and inspection readinessDevelop and track KPIs to measure data governance effectiveness and generate reports for leadershipEvaluate and implement data quality tools and technologies to improve operationsDrive digital innovation in data governance activitiesCoordinate system upgrades, integrations, and enhancements affecting regulatory data integrityLead efforts to establish authoritative datasets and improve data quality Key requirementsBA/BS in Life Sciences, Information Management, Regulatory Affairs, or related field with 10+ years' experience; MA/MS with 8+ years; PharmD/PhD with 5+ yearsExtensive experience leading data governance and stewardship in a regulated environmentExperience in regulatory information domains related to product development and lifecycle managementProven track record establishing authoritative data assets and data quality governanceStrong ability to influence across a matrixed organization and drive cross-functional initiativesExperience leading large-scale global regulatory change initiativesCertifications in PMP, change management, or Six Sigma/Lean are a plusStrong communication, negotiation, and conflict resolution skillsWillingness to travel when neededKnowledge of biopharma regulatory requirements (FDA, EMA, ICH) and data privacy regulations (GDPR, HIPAA)Experience with tools like Veeva, Docubridge, Collibra, Informaticacollaborationstakeholder influenceanalytical thinkingdata governancedata stewardshipKPI design and reporting
Not specified in the original listing.
Not specified in the original listing.
