Manager, CMC Regulatory Compliance (GRA, CMC)
This job is no longer available
There are still lots of open positions. Let's find the one that's right for you.
About The Position
Takeda Development Center Americas, Inc. is seeking a Manager, CMC Regulatory Compliance (GRA, CMC) with the following duties: Execute process excellence solutions and monitoring compliant execution of global and local operational activities within Global Regulatory Affairs - Chemistry, Manufacturing and Controls (GRA CMC); maintain working knowledge and ability to interpret/apply major market regulations such as Code of Federal Regulations (CFR) Title 21 and EU GMP Guide for Medicinal Products and the EU GMP Guide for Active Substances as well as ICH guidance (ICH Q7, ICH Q9, and ICH Q10); partner with cross functional colleagues in Quality Assurance, Global Manufacturing, and Local Operating Companies to execute on continuous improvement solutions and drive successful CMC regulatory compliance; engage in Quality Management System operational activities (Quality Events, Corrective and preventative Action, GxP Training, etc.) and act as a point of contact for Regulatory CMC on audits & Inspections; maintain experience with pharmaceutical industry applications such as: TrackWise or equivalent QMS applications, EDMS for controlled document management, GxP Learning Management Systems and curricula management; support a program for the tracking, execution, monitoring, and reporting on GRA CMC processes (Metrics and KPIs) to drive pre and post submission activities (must have experience with commercial analytics applications such as Power BI, QLIK Sense); contribute to the design of optimized CMC capabilities through digital solutions and automation enablement for optimal execution and compliance; communicate with CMC Regulatory Compliance leadership to ensure clear and timely communication about business processes, compliance activities, issues/problems, and metrics.
