Manager, CMC Regulatory Compliance (GRA, CMC)

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Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity:

JOB LOCATION: Cambridge, MA

POSITION: Manager, CMC Regulatory Compliance (GRA, CMC)

POSITION DESCRIPTION: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.

REQUIREMENTS:Bachelor’s degree in Pharmacy, Regulatory or a related field plus 4 years of related experience. Prior experience must include: Implement fundamental knowledge of the applicable GXP (GMP, GCP and GVP) regulations and guidance and ICH Guidelines to define compliant Standard Operating Procedures; Utilize knowledge of the pharmaceutical drug development lifecycle to analyze, design and implement process improvements cross- functionally to enhance operational efficiency; Contribute and research the design and implementation of digital solutions and automation; Manage and execute operational activities related to quality events, CAPA, change controls, and health authority inspections; Ensure formal risk assessment, impact analysis, and develop responses to GXP Quality events; Track, analyze, and report on metrics and KPIs to meet organizational goals; Manage and track team projects, their timelines, and deliverables to ensure their completion in a timely manner; up to 50% remote work allowed.

Full time. $108,500.00 - $186,000.00per year. Competitive compensation and benefits.

Qualified applicants can apply athttps://jobs.takeda.com. Please reference job #R0145046. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.