Chargé de la Qualité et Conformité en alternance pour Economie d’Energie. Soutenir la conformité et le contrôle interne tout en participant à la transition énergétique en France.
About the role
- Director of Regulatory Vault Operations overseeing GSK’s regulatory systems and leading strategic initiatives. Responsible for compliance and efficiency in regulatory submissions across a global landscape.
Responsibilities
- Set the strategic direction and lead the delivery of Regulatory Vault Continuous Improvement.
- Oversee and optimize the technology infrastructure and digital platforms supporting regulatory and development operations.
- Partner with Tech and R&D Quality teams to ensure full GxP validation and prepare for regular inspections.
- Develop and execute strategies that integrate system operations, reporting and analytics, and support services.
- Work closely with cross-functional teams to ensure cohesive efforts in system operations and support services.
- Identify and implement innovative solutions and best practices to enhance system operations and reporting.
- Ensure all systems, reporting, and support services adhere to regulatory guidelines and standards.
- Lead, mentor, and develop a high-performing team to support GSK’s regulatory and development objectives.
Requirements
- An advanced degree in a relevant discipline such as Regulatory Affairs, Pharmaceutical Sciences, Biotechnology, Business or a related field.
- Expert level knowledge of Veeva Regulatory Vault and the Vault platform including configuration and customization capabilities.
- Strong experience working within the pharmaceutical, biotechnology or life sciences industry, focusing on regulatory affairs, clinical development or regulatory operations.
- Strong experience with service management around enterprise systems, including change and release management and end user support.
- Strong experience with GxP validation, inspection readiness, and Quality Management Systems including management and resolution of deviations, CAPAs, and findings.
- Deep knowledge of regulatory and development systems, including platforms supporting submissions, tracking and regulatory operations (e.g. RIM, eCTD and related environments).
- Proven expertise in data, reporting and analytics, using insights to support decision-making and operational performance.
- Demonstrated experience leading senior, cross-functional teams and delivering strategic initiatives in complex, matrixed organisations.
- A solid understanding of global regulatory requirements and compliance, with the ability to manage risk and ensure data integrity across systems and processes.
- Experience operating in global environments, working across multiple regulatory regions and health authorities.
Benefits
- Private healthcare
- Additional paid days off
- Life insurance
- Private pension plan
- Fully paid parental leave & care of family member leave
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