Director, Data Governance, Standards & Quality (Regulatory Affairs)

Overview

The Director, Data Governance, Standards and Quality (DGSQ) within Regulatory Data Management will ensure the governance, quality, and effective use of regulatory data and information management systems to meet GSK''s Regulatory, Pharmacovigilance, and GMP-compliance obligations. This role is critical for enabling business efficiencies and ensuring data interoperability across GSK''s Regulatory Affairs, RandD, and Global Supply Chain functions. The DGSQ Director will lead a team responsible for ensuring compliance with regulatory data standards, implementing data governance frameworks, overseeing data quality and remediation, and driving interoperability across GSK''s enterprise data systems. Additionally, this role will focus on optimizing the use of Veeva Vault systems, ensuring compliance readiness for health authority standards, and driving innovation and continuous improvement in regulatory systems and processes. The role requires collaboration with key stakeholders across Global Regulatory Affairs, Supply Chain, RandD functions, Tech and external vendors to align priorities, maximize business value, and deliver on strategic objectives. The DGSQ Director will also lead matrix teams and serve as a change agent to embed regulatory data standards and governance practices across the organization.Responsibilities

Data Governance Framework: Embed and oversee a regulatory data governance framework to monitor and ensure data quality, compliance, remediation, and interoperability.Regulatory Compliance: Ensure compliance with internal regulatory data policies and practices, as well as external standards (e.g., IDMP, xEVMPD, eAF, SPOR, GxP).Subject Matter Expertise: Serve as a structured data SME, partnering with GRA Process Leads and external peers to support business needs and promote continuous improvement.Enterprise Collaboration: Work collaboratively with enterprise teams and external vendors to optimize RIM data functionality, ensure interoperability, and drive operational efficiency.Data Analytics Strategy: Define strategies for analytics, reporting, and monitoring to support data governance, in-process controls, and business processes.Data Remediation: Prioritize remediation and enrichment activities to ensure compliance and optimal data quality.Business Process Analysis: Analyze regulatory data requirements across vaccines and pharmaceuticals to ensure compliance and streamline processes.Drive Data Standards Adoption: Champion regulatory data standards and embed data quality practices within system and process communities.Regulatory Process Optimization: Develop and maintain processes for managing data flow, storage, and integration across applications and business domains.Leadership and Change Management: Lead a high-performing team, acting as a change agent to drive adoption of agile approaches and deliver value-based solutions.Qualifications

EducationBachelor''s degree in Life SciencesPreferred Education: Advanced degree in Life SciencesExperience and Skills

Minimum Requirements: Extensive experience in Pharmaceutical Regulatory Affairs, including global regulatory procedures and RIM systems.Demonstrated business analysis skills to identify solutions and areas of process/system improvement.Ability to work independently and lead teams to meet objectives.Experience with complex IT system landscapes involving Tech, Quality, and Training organizations.Proven ability to lead matrix teams in a globally diverse organization.Deep understanding of regulatory data standards (e.g., XEVMPD, IDMP) and regulatory requirements.Experience with validated, regulated systems and RIM systems subject to inspection.Familiarity with Scaled Agile Framework principles.Preferred Requirements:

Experience managing staff across multiple locations.Project management expertise, including prioritization across multiple sites and stakeholders.Demonstrated business analysis skills to identify solutions and areas of process/system improvement.Ability to work independently and lead teams to meet objectives.Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we''re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK''s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at ..... full job details .....