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Job Description

Job Title: Head RDQCS Compliance

Location: Cambridge, MA

About the role:

Leads the global R&D Quality Compliance organization, providing oversight of 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.

• Establishes the framework for quality oversight of the R&D Quality Management System.

• Serves as a strategic Quality Partner to Compliance leads across R&D Quality and the Enterprise Global Quality organization.

• Key member of the RDQCS Leadership Team, contributing to the design, implementation and advancement of the R&D Quality Management System strategy, model and operations.

How you will contribute:

• Responsible for the RDQ framework of audit and inspection management, inspection readiness, gap assessments, risk management and incident escalation.  Builds strategic plans for R&D audit programs and inspection preparation to minimize critical observations and ensure Takeda’s regulatory reputation remains positive with global authorities in coordination with R&D Quality leadership.

• Leads the systematic application 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.

• Owner 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 strategic oversight of the 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.

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

• Leads representatives from across R&D/R&D Quality those who serve as system owners for centrally accessed QMS processes Advances R&D/RDQ-wide forums to increase awareness, foster cross-functional learning, and improve knowledge.  Works with system owners to develop metrics, trending programs, and continuous improvement plans for processes and systems used across R&D/R&D Quality.

• Define, lead, and implement critical projects which enhance RDQ’s efficiencies and innovation.  Engage in global, enterprise-wide cross-functional project and programs on behalf of RDQ to serve key business partners in R&D/R&D Quality.

• Provides subject matter expertise and consultation for R&D Compliance related to deviations, CAPAs, change controls, responses to inspection outcomes and incident escalations.  Escalates issues and incidents with regulatory authorities in coordination with  R&D and R&D Quality leadership.

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 process