Global Quality Account Manager

4 weeks ago


Letterkenny, Donegal, Ireland TN Ireland Full time

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Client:

Phillips-Medisize

Location:Job Category:

Other

EU work permit required:

Yes

Job Reference:

db4affcbcb28

Job Views:

1

Posted:

29.03.2025

Expiry Date:

13.05.2025

Job Description:

Your Job

Phillips-Medisize is seeking a Quality Account Manager to be the key quality contact for strategic customers involving multiple Phillips-Medisize manufacturing locations and GID centers, mainly supporting our platform business from Design and Development through Commercialization.

What You Will Do

  1. Design & Development Stage
    • Be the contact window to transfer quality documentation from GID centers to multiple Phillips-Medisize manufacturing locations, also be the quality leader to ensure all the quality deliverables from manufacturing locations could meet the requirements during Design & Development stages. Work directly with the Regulatory Affairs Team to ensure alignment and any gaps are addressed.
  2. NPI & Mass Production Stages
    • Lead and coordinate the NPI AQP processes in terms of quality responsible areas by leveraging the quality resources from different quality organization in multiple Phillips-Medisize manufacturing facilities producing for the common strategic customers.
    • Drive the customer relationship management process between all Phillips-Medisize facilities and the strategic customer quality organizations, act as principal quality liaison between Phillips-Medisize facilities and the strategic customer, responding appropriately to internal and external customer needs.
    • Negotiate, review and approve the quality agreements and other quality requirements from strategic customers.
    • Participate in regular business reviews providing quality updates on the behalf of all Phillips-Medisize facilities producing for the strategic customers.
    • Track and report quality improvement initiatives and action items for the strategic customers.
    • Participate in post market changes, feedbacks and complaints, as well as the reporting to authorities by the assistance from the manufacturing locations and regional RA representatives.
    • Coordinate with internal RA (Regulatory Affairs) Teams or external RA consultants coordinating registration and post market regulatory activities are met for various global jurisdictions / markets.

Who You Are (Basic Qualifications)

  • Several years of experience in Project/Quality engineering.
  • Be familiar with ISO13485, QSR 820, NMPA regulations etc.

What Will Put You Ahead

  • RA (Regulatory Affairs) background
  • Technical injection molding tooling, materials, manufacturing, quality, and product design skills.
  • Leadership skills including ability to maintain confidentiality and drive projects and new business processes, ie. project management.
  • Business insights and strategic thinking including ability to handle top pharma company expectations.
  • Embrace diversity (culture and personality).
  • Demonstrated superior communication, teamwork, and organizational skills.
  • Ability to develop and meet project/program schedules, along with contingency plans.
  • Ability to travel to Customers or Manufacturing Sites at least 10% of the time.
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