Manager, Global Regulatory Affairs Facilities

Basic qualifications:

•Bachelors degree (Science) and at least 5 years of relevant experience 
•Knowledge and experience in US regulations pertinent to CMC Establishments/GMP 
•Knowledge and experience in CMC Establishments/GMP/ Equipment Validations

Preferred qualifications:

•Experience in QA/CMC
•Experience in interacting with external organizations and Health Authorities pertaining to regulation of CMC establishments and QA
•Experience in providing strategic advice on CMC Establishments/ Equipment Validations in cross-functional teams
•Experience in securing approvals and life cycle maintenance for CMC Establishment Regulatory function 
•Detailed knowledge of CMC, QA preferred, especially in Vaccines/Biologicals 
•Demonstrated organizational skills 
•Demonstrated written and oral communication skills 
•Ability to strategize, problem solve and influence

Details:
Be part of a new team for an exciting and growing business and world’s leading vaccine organization in our new R&D Center in Rockville, Md.

You will have the opportunity to be on the ground floor of a new organization and site, and you will be part of a new culture of some of the best scientific minds in vaccine research. Come deliver the GSK Vaccines strategy by driving vaccine R&D projects through innovation, collaboration, cutting edge science, exceptional people, and end-to-end quality performance.

Contributes to strategic plans in collaboration with GSK Bio Regulatory, GSK Bio manufacturing Site Regulatory, GSK Bio US Regulatory Therapeutic Area Heads, Validation, Global QA to provide regulatory guidance and strategy for assigned projects/facilities 

Contributes input to CMC Establishment Strategy on assigned project teams in addressing facility (and CMC as appropriate) projects, orchestrate the strategy and technical responses to FDA/ Health Authority inquiries. 

Responsible for managing efforts to ensure the timely approval of submissions to ensure positive impact on the supply chain of the business for assigned projects/facilities 

Contributes to/supports regulatory input/assessment regarding planned process and facility changes in advance of implementation for assigned projects/facilities 

Provides regulatory/quality guidance to manufacturing sites to ensure timely and strategic implementation of changes and appropriate documentation in compliance with GMPs. 

Supports/advises GSK Bio integration and expansion plans for assigned manufacturing sites by providing strategic regulatory support and guidance for implementation of GSK Bio Global procedures (RPC, Establishment Documentation Templates, Inspection Preparation).

Contact information:
You may apply for this position online by selecting the Apply now button.

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