7 years pharmaceutical quality assurance experience
Aseptic filling manufacturing experience
Fda/eu cgmp regulatory knowledge
**
Roche is seeking an Associate Manager for Quality and Compliance in Biologics in Shanghai, China. The role involves ensuring compliance with quality management systems, overseeing regulatory inspections, and providing training on quality assurance topics. The ideal candidate will have extensive experience in quality assurance within the pharmaceutical or biotechnology sector.
**
Job Summary
The role involves mobilizing new sites from a quality and compliance perspective while developing resources to ensure full adherence to Roche's quality management system.
Candidates must possess in-depth knowledge of US and EU GxP requirements and have proven experience managing regulatory inspections with global health authorities.
Roche fosters a culture of personal expression and genuine connections where every employee is valued for their unique qualities.
Matching Summary
Match Score: 75
**
Roche is seeking an Associate Manager for Quality and Compliance in Biologics in Shanghai, China. The role involves ensuring compliance with quality management systems, overseeing regulatory inspections, and providing training on quality assurance topics. The ideal candidate will have extensive experience in quality assurance within the pharmaceutical or biotechnology sector.
**
Skills & Requirements
Must-have
7 years pharmaceutical quality assurance experience
Aseptic Filling manufacturing experience
FDA/EU cGMP regulatory knowledge
New facility startup readiness expertise
Regulatory inspection management skills
Nice-to-have
Strong stakeholder management abilities
Agile problem-solving capabilities
Fluent English communication skills
Experience with SAP or Veeva tools
International regulatory network exposure
Key Requirements
Degree in pharmaceutical sciences or related discipline