MINIMUM EDUCATION:

• Bachelor’s degree in Life Sciences

PREFERRED EDUCATION:

• Advanced degree in Life Sciences

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.

JOB PURPOSE

The Director, Data Governance, Standards & 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, R&D, 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, R&D 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.

KEY 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.