Associate Director, Regulatory Data Quality

Gilead Sciences; Foster City (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Gilead is seeking an Associate Director, Regulatory Data Quality to implement and operationalize data governance across Regulatory Affairs. The role ensures data integrity, quality, and compliance with global regulatory data requirements while aligning with cross-functional teams.

The position focuses on data stewardship, governance, and improving data management practices to support regulatory submissions and lifecycle management across programs.

Qualifications

• Experience leading data governance and stewardship in a regulated environment.
• Strong understanding of regulatory information and product lifecycle data.
• Exposure to FDA/EMA regulatory data requirements and inspections.

Responsibilities

• Operationalize data stewardship and governance framework across regulatory data domains.
• Drive data integrity and quality initiatives for Regulatory Affairs.
• Collaborate with cross-functional teams to align data standards and definitions.
• Act as data steward ensuring data completeness, accuracy and reliability.
• Develop and track KPIs for governance initiatives and report to leadership.

Skills

Data governance

Data stewardship

Regulatory data

Cross-functional collaboration

Regulatory compliance

Education

BA/BS Life Sciences or related

MA/MS in related field

PharmD/PhD in related field

Job description

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.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

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 Associate Director, Regulatory Data Quality will be responsible for implementing and operationalizing data quality stewardship capabilities across Regulatory Affairs. The role will translate data governance strategies, standards and frameworks into practical ways of working that improve the quality, integrity, consistency and usability of regulatory data.

Regulatory data is 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 have a strong focus on the execution of data stewardship, data quality monitoring and remediation, governance processes, metrics and continuous improvement. The incumbent will help embed clear accountability for regulatory data and support the adoption of good data management behaviors throughout the 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) RA Data Governance Team with considerable responsibilities to develop, continuously improve and innovate global regulatory practices, processes, tools, team, and other capabilities.

EXAMPLE RESPONSIBILITIES:

• Operationalize the Regulatory Affairs Data Stewardship framework, standards and operating model across regulatory functions and data domains.
• Supports the Regulatory Affairs Data Governance Council and drives the overall approach for data integrity and quality for the organization.
• Evolve the design and implementation of 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 framework that crosses organizational boundaries.
• Partner with a matrixed team of representatives from the data domains across the organization
• Partner with regulatory subject matter experts to document business definitions, data standards, ownership and data quality requirements.
• Support alignment of Regulatory Affairs data standards with broader cross-functional and enterprise data initiatives.
• Act as a steward for regulatory data, ensuring data quality, completeness, and reliability.
• Ensures 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 establish authoritative datasets, data governance priorities and objectives.
• Provide guidance to functions on data governance and stewardship best practices for their organization.
• Evaluate and implement data quality management tools and technologies to improve business operations and data quality.
• Drives digital innovation across the data governance activities and approaches.
• Collaborate with development systems and data owners to manage system upgrades, integrations, and enhancements related to regulatory data integrity and quality.
• Develop and track key performance indicators (KPIs) to measure the effectiveness of data governance initiatives.
• Generate reports for senior management and functional leadership as needed on state of regulatory data.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Education & Experience

• 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.
• Experience in life sciences/biotech industry. Extensive experience leading data governance and stewardship capabilities in a regulated environment.
• Strong experience in the domains of regulatory information and how they relate to the product development and lifecycle management activities of our portfolio (i.e. product registrations/licenses, investigational and marketing applications, submission content, label tracking, variations)
• Significant experience and significant successes establishing authoritative data assets and developing operating constructs to ensure data integrity and quality.