Here's What You'll Do:

* Implement, execute, maintain and improve processes for sharing relevant dossier parts amongst the Moderna network and with 3rd parties.
* Implement, execute, maintain and improve the processes for assessing Deviations with potential impact to the registered details and ensure systematic implementation to ensure continuous compliance with the dossier
* Provide assessments and guidance on regulatory compliance impact assessments of Change Controls, Specification Management, Deviations and other QMS processes as required.
* Support quality-related information requests raised by partners/customers and International Health Authorities
* Support review and approval of regulatory documentation to improve compliance including compliance checks as required
* Act as a Subject Matter expert for dossier content related questions and provide training and learning to the INTL team on the content and interpretation of the dossiers.
* Provide cross functional quality leadership and act as a GXP compliance subject matter expert on technical matters involving product examination, testing and disposition, quality investigations, validation, data integrity, and in business matters involving facility and laboratory operations.
* Work collaboratively with the digital team on the GXP integrated digital landscape to support all electronic quality systems, the utilisation of data to accelerate and inform process and system performance and value stream roadmaps for long range planning.
* Support and lead programs strengthening the regulatory compliance of Moderna and support continuous improvement for the rapidly expanding GXP international environment.
* Engagement in external committees to systematically influence the industry

Here's What You'll Bring to the Table:

* 12 years+ experience in Regulatory Compliance or equivalent functions in GxP-regulated Pharmaceutical Industry
* Bachelor's degree or higher, preferably in Sciences or Engineering
* Proficient in English, additional languages are a plus
* Proactive Team Player with strong interaction skills who will flourish in a dynamic environment
* Ability to manage stakeholders at all levels and achieve in a matrix organisation
* Proven track record in management of regulatory dossier compliance reviews
* Proven track record in solution-oriented handling of complex regulatory impacting Change Controls and Deviations
* Travel up to 20%