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Device Quality Product Surveillance Lead

Company: Takeda Pharmaceutical Company Ltd
Location: Lexington
Posted on: June 13, 2021

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Device Quality Product Surveillance Lead in our Boston office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Device Quality Product Surveillance Lead working on the R&D Quality team, you will be empowered to actively lead and manage strategic GMP QA activities with Takeda development programs, ensure compliance with regulations & Takeda Quality Standards related to manufacturing testing, packaging, & distribution of investigational drug product and investigational active pharmaceutical ingredients. You will also be accountable to Identify compliance gaps and propose solutions, independently manage projects and make sound decisions related to product quality issues, and mentor other members of the GIQ team. A typical day will include:

OBJECTIVES/PURPOSE

Device Quality Product Surveillance Lead is an experienced Quality and Technical professional who supports the overall device and combination product quality strategy to maximize the benefit and sustainability of Takeda's in-line products and to bring Takeda's pipeline products to a sustainable existence on the market.

  • Drives improvements for Device and Combination Products(DCP) and ensures robust post market and clinical product review. Oversight on clinical and commercial DCP complaints trending
  • Customer Focus
  • Product and Process Surveillance

  • Participates in ongoing Quality initiatives, Integration support and Operational Excellence.
  • Assesses product quality performance, including visual management, to demonstrate levels of control, capability and compliance. Responsible for assessment of trending for all key KPIs.
  • Responsible for global product surveillance data, including customer focus, product risks and performance capability.
  • Device and Combination Products post market surveillance and clinical reviews
  • Interaction with APQR/PQR group to ensure combination products data is captured.

ACCOUNTABILITIES

  • Provides input to incidents investigations, complaints, non-conformances, CAPAs and change controls
  • Surveillance and monitoring device and combination products lifecycle management
  • Assessment of customer complaints, trending of complaints, accountable for device CAPA support, MDR/Vigilance reporting and updating all risk-related reports if required of specific medical devices, in addition to Incident escalation execution for Device and Combination products as necessary.
  • Internal and external audit support including site readiness.
  • Influences QMS strategy to enhance and execute sustainable Device Quality support for internal and external manufacturing, packaging, testing and release of device and combination products.
  • Management of Post Market Surveillance process and schedule for Takeda DCP portfolio

This job posting excludes CO applicants.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Keywords: Takeda Pharmaceutical Company Ltd, Boston , Device Quality Product Surveillance Lead, Other , Lexington, Massachusetts

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