Director, Data Governance, Standards & Quality (Regulatory Affairs)
Director, Data Governance, Standards & Quality (Regulatory Affairs)
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Job Description
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 GSKs Regulatory Pharmacovigilance and GMP-compliance obligations. This role is critical for enabling business efficiencies and ensuring data interoperability across GSKs 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 GSKs 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.
Knowledge/Education Requirements
Minimum Education:
- Bachelors degree in Life Sciences
Preferred Education:
- Advanced degree in Life Sciences
Previous Experience Requirements
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.
Why GSK
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 were 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.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0. The helpline is available from 8.30am to 12.00 noon Monday to Friday during bank holidays these times and days may vary.
Please note should your enquiry not relate to adjustments we will not be able to support you through these channels. However we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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 GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
Director
Employment Type
Full-Time
Key Skills
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