(associate) Manager, Qs & Compliance, Biologics

Roche UK

Shanghai, China
Gxp and quality system requirements
Manage regulatory inspections
Aseptic filling experience
The Position Quality and Technical Guidance Support mobilisation of new sites from a quality, compliance perspective

Job Summary

  • The Position Quality and Technical Guidance Support mobilisation of new sites from a quality, compliance perspective.
  • Provide strategic direction and manage execution of regulatory inspections, internal and external audits and paper-based inspections.
  • Develop and deliver training programs on quality assurance topics, ensure relevant employees are adequately trained on quality standards and procedures, and evaluate the effectiveness of training programs to enhance knowledge and compliance.

Matching Summary

The Position Quality and Technical Guidance Support mobilisation of new sites from a quality, compliance perspective.

Skills & Requirements

Must-have

  • GxP and Quality System requirements
  • Manage regulatory inspections
  • Aseptic Filling experience
  • FDA/EU cGMP know-how
  • Veeva
  • SAP
  • Orca

Nice-to-have

  • Agile skills with flexibility
  • Independent problem-solving
  • Critical thinking abilities
  • Diplomatic communication
  • Personal expression
  • Open dialogue
  • Genuine connections

Key Requirements

  • Minimum 7 years experience in pharma/biotech
  • Degree in pharmaceutical sciences or related
  • New DP facility project experience
  • Fluent English communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter