Gxp Supplier Quality Manager

Roche UK

Shanghai, China
On-site
Gxp supplier lifecycle oversight
Quality agreements and product specific requirements
Collaboration with gxp suppliers on quality issues
Roche UK is seeking a GxP Supplier Quality Manager to oversee quality activities related to GxP suppliers, ensuring compliance with quality standards and regulations. The role requires collaboration with suppliers and internal teams, focusing on maintaining product quality during various phases of the supplier lifecycle

Job Summary

  • Oversee all required quality activities during the lifecycle of a GxP supplier, including process validations, audits, and investigations.
  • Develop, negotiate, and maintain Quality Agreements with GxP suppliers and partners, ensuring compliance with agreements.
  • Collaborate with GxP suppliers to address quality gaps and drive resolution of complex manufacturing or quality problems.

Matching Summary

Match Score: 85

Roche UK is seeking a GxP Supplier Quality Manager to oversee quality activities related to GxP suppliers, ensuring compliance with quality standards and regulations. The role requires collaboration with suppliers and internal teams, focusing on maintaining product quality during various phases of the supplier lifecycle.

Skills & Requirements

Must-have

  • GxP supplier lifecycle oversight
  • Quality Agreements and Product Specific Requirements
  • Collaboration with GxP suppliers on quality issues
  • Product release, rejection, or quarantine
  • Quality risk management plans
  • Technical transfers for manufacturing and packaging
  • Fluency in oral and written English

Nice-to-have

  • Operational Excellence expertise
  • Additional language skills
  • Mentoring and coaching colleagues

Key Requirements

  • B.A. or B.S. degree in life sciences or equivalent
  • Previous experience in pharmaceutical or related industry
  • Experience with GxP suppliers (CMO, CLO, direct material)
  • Sound knowledge of cGMP, ISO standards, and international regulations
  • Ability to interpret quality standards for GxP suppliers
  • Highly competent in MS Office or Google Suite applications
  • Up to 10% domestic and/or international travel

Work Rights

Not specified

Tailored Resume

Cover Letter