Develop, manage and contribute to ongoing maturity of GMP and GDP Inspection Readiness Plans associated with regulatory filings and real-time inspection readiness activities.
Work directly with CMOs and the Company Manufacturing Center on inspection readiness activities, including identification of potential inspection risks.
Work with internal teams on key issues to ensure inspection readiness.
Develop project management plans with key metrics.
Provide PM oversight of readiness activities.
Build and maintain dashboards.
Contribute to ongoing maturity/growth of the inspection readiness program.
Assist with developing and providing oversight of mitigation plans.