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Job Description

Job Title: RDQCS Compliance Lead

Location: Cambridge, MA

About the role:

Member of the global R&D Quality Compliance organization, providing cross functional expertise and strategic input to the quality systems supporting Takeda’s R&D Quality organization across the RDQ enterprise and ensuring that it is robust, aligned with, and compliant to applicable regulatory requirements, and governed and positioned for continual improvement.

• Provides key input to the establishment of the framework for quality oversight of the R&D Quality Management System.

• Serves as a Quality Partner across R&D Quality.

• Contributes to the design, implementation and advancement of the R&D Quality Management System operations.

How you will contribute:

• Responsible for autonomously executing activities associated with the RDQ framework of audit and inspection management, inspection readiness, gap assessments, risk management and incident escalation.  Partners with RDQ to develop plans for R&D audit programs and inspection preparation to minimize critical observations and ensure Takeda’s regulatory reputation remains positive with global authorities.

• Responsible for the implementation of Risk Management principles across RDQ, ensuring consistency of approach and compliance to SOPs.  Responsible for authoring, editing, and circulating for approval the associated family of documents.

• Ensures the execution of the RDQ Regulatory Intelligence program, reviewing, documenting and gap assessing global regulatory changes across all GxPs (GMP, GCP, GDP, GLP, PV) used within R&D/R&D Quality to ensure continued compliance with current global regulations.

• Accountable for application of the gap assessment process, ensuring consistency of approach and compliance to SOPs.  Responsible for identifying and executing on process improvements that are identified associated with the process.

• Stewards the R&D Quality Management System, ensuring R&D and R&D Quality remain in compliance with Global GxP regulations in coordination with the R&D Quality Compliance team.  

• Serve as system owner for centrally accessed QMS processes Advances R&D/RDQ-wide forums to increase awareness, foster cross-functional learning, and improve knowledge.  Develops metrics, trending programs, and continuous improvement plans for processes and systems used across R&D/R&D Quality.

• Leads and independently executes projects which enhance RDQ’s efficiencies and innovation.  Engages in global, enterprise-wide cross-functional projects and programs on behalf of RDQ.

• Provides subject matter expertise and consultation for R&D Compliance related to deviations, CAPAs, change controls, responses to inspection outcomes and incident escalations.

What you bring to Takeda:

• Bachelor’s Degree in Chemistry, Biology, Engineering, or related field.

• Minimum of 10 years professional working experience in the field of healthcare products or related activities such as pharmaceutical or device manufacturing, Quality Control or Quality Assurance including at least 4 years in GMP Quality or Compliance.

• Six sigma/lean processing, project management professional and/or auditor certification preferred

Technical/Functional (Line) Expertise  

• Working knowledge of current GxP (e.g,, Good Manufacturing Practice, Good Laboratory Practices, Good Clinical Practices, Pharmacovigilance) requirements for the