Engineering Quality Associate Manager, Biologics

Roche(25 days ago)

ShanghaiOnsiteFull TimeManager$115,122 - $152,668 (estimated)Quality Assurance

About this role

Engineering Quality Manager for a greenfield large-molecule drug product facility in Shanghai responsible for ensuring CSV, data integrity, and validation activities are planned and executed in line with Roche standards and applicable regulations. The role sits within the project quality team reporting to the Quality Head of Biologics and provides oversight and guidance across design, qualification, and validation phases to maintain compliance through to site approval. It supports cross-functional collaboration to enable successful delivery of the project.

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Required Skills

CSV
Data Integrity
Validation
Commissioning
Qualification
GMP
Risk Assessment
Project Management
Leadership
Aseptic Filling

Qualifications

Bachelor's Degree in Science (Pharmaceutical, Chemistry, Biochemistry, Mechanical or Automation)

About Roche

roche.com

As a pioneer in healthcare, we have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally.

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