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Job Description

Job Title: R&D Quality Services Improvement Leader

Location: Cambridge, MA

About the role:

Provides leadership and oversight of the quality services improvement supporting Takeda’s R&D Quality organization across the RDQ enterprise, interacting with RDQCS leadership and representatives from R&D Quality functional areas.  Ensures RDQCS business and compliance processes are robust, aligned with, and compliant to applicable regulatory requirements, governed and positioned for continual improvement.

• Designs Quality Strategies to drive improvement, innovation, and predictive quality measures, in partnership with RDQCS LT.

• Demonstrates leadership in the RDQCS organization to promote strategic thinking and innovative approaches, driving Change Management to facilitate transformation, integration, and improvement initiatives across the organization.

• Oversees budget and resource management for the RDQCS, partnering with Head of RDQCS, RDQCS LT, Finance and others as needed.

• Interprets RDQCS metrics to identify and communicate compliance risks and liaise with appropriate R&D/R&D Quality functions to drive organizational process improvements.

How you will contribute:

• Leads the development of the RDQCS strategic development in alignment with the GQ and RDQ Strategies, including long- and mid-range plans aligned to growth/pipeline development, network strategy and business imperatives by providing input to key strategic, pipeline, and financial decisions.

• Monitors progress toward RDQCS goals and works across the organization to develop KPI reports and metrics.  Intervenes and escalates, as necessary, to ensure that RDQCS is on track to meet or exceed performance targets.  Provides complex analysis and insight in evaluating overall organizational performance over time and for future planning.

• Serves as a strategic thought partner to the Head of RDQCS and the RDQCS leadership team with regards to complex problems, current and future initiatives, strategies, and budget.  Looks across R&D Quality to identify efficiencies and interdependencies to ensure optimal working models.

• Builds and maintains a communication strategy, plan and platform for RDQCS.  Partners across RDQ to ensure efficient, effective communication and decision making.

• Provides professional expertise and strong leadership in RDQCS guidance and regulations.

• Defines, leads, and implements critical projects which enhance RDQ’s efficiencies and innovation.  Engage cross-functionally on behalf of RDQ to serve key business partners.

What you bring to Takeda:

• Minimum of 6 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 GXP Quality or Compliance.

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

• 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 pharmaceutical industry

• Experience in compliance and systems related processes and tasks

• Experience with risk management strategies and general project management

• Proven success in identi