Director, Regulatory Affairs Data Governance Lead

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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.
 

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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 Data Governance Lead for Regulatory Affairs will be responsible for defining, implementing, and overseeing data governance strategies and frameworks within the regulatory affairs domain. Regulatory information assets are a core asset for regulatory affairs and the broader enterprise at Gilead, this leader will ensure data integrity and quality expectations are embedded into the ways of working within the organization. This role ensures compliance with global regulatory data requirements, drives data quality initiatives, and facilitates alignment between global regulatory affairs and cross-functional teams.

The role will provide strategic input and operational leadership for data domain teams that will focus on data quality throughout the regulatory affairs organization. The incumbent will collaborate with patient safety, quality, regulatory CMC, commercial, clinical, and other development organizations on data governance activities that interfaces with end-to-end regulatory processes. The role will align and leverage broader master data management initiatives that exist within the development systems and information technology organizations.  The role will lead efforts to improving our data quality through establishing authoritative datasets and leveraging innovative technologies.

You will be a member of the Innovation, Digital and External Partnerships (IDEP) Leadership Team with considerable responsibilities to develop, continuously improve and innovate global regulatory practices, processes, tools, team, and other capabilities.

EXAMPLE RESPONSIBILITIES:

• Leads the Regulatory Affairs Data Governance Council and drives the overall approach for data integrity and quality for the organization.

• Designs and implement a comprehensive data governance framework that is fit for purpose for Regulatory Affairs data and processes.

• Accountable for driving an effective and integrated cross functional data governance that crosses organizational boundaries.

• Leads a matrixed team of representatives from the data domains across the organization

• Define data standards, policies, and procedures to ensure consistency, accuracy, and compliance across the organization.

• Act as the custodian for regulatory data, ensuring data quality, completeness, and reliability.

• Ensure all regulatory data adheres to local, regional, and global compliance requirements, including FDA, EMA, and other regulatory bodies.

• Partner with quality and compliance teams to stay updated on evolving regulatory standards and inspection readiness expectations, integrate needs into data quality practices.

• Collaborate across Regulatory Affairs functions and Quality to est