Global Quality Account Manager
4 weeks ago
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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
- 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.
- 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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