Associate Director, Regulatory Data Quality

Onsite - Hybrid Eligible

United States - California - Foster City

Full time

R0056384

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.

• Strong track record of successes working and negotiating across organizations in a matrixed environment.

• Experience in leading high-complexity, large-scale, cross-functional global change initiatives in regulatory affairs.

• Certifications in PMP, change management, or Six Sigma/Lean are a plus.

• Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.

Knowledge & Other Requirements

• Strong knowledge of the biopharma industry, including in-depth understanding of regulatory affairs and adjacent business functions, as evidenced by proven achievement in short- and long-range strategies, plans, and objectives.

• In-depth knowledge of systems, tools, metrics, and digital technologies to support regulatory affairs and broader data governance (i.e. Veeva, Docubridge, Collibra, Informatica).

• Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH).

• Knowledge of data privacy regulations (e.g., GDPR, HIPAA) and their implications for regulatory data management.

• Demonstrates ability to rapidly become acquainted with Gilead’s current ways of working and data quality approaches.

• Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications.

• Proven ability to influence up, down, and across the organization and externally in a collaborative manner.

• Strong communication and organizational skills.

• Able to distill complex matters into a clear business case and roadmap for execution.

• Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans, and strategic objectives.

• Advanced meeting facilitation, organizational, and communication skills.

• Strong negotiation and conflict resolution skills.

• When needed, ability to travel.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.