Qv Lead, Biologics

Roche

Shanghai, China
Not specified
7 years pharmaceutical qa or qv experience
Aseptic filling facility experience required
New dp facility startup readiness
Roche is seeking a Qv Lead for its Biologics division in Shanghai, China, to ensure projects comply with corporate and regulatory standards. The role requires extensive experience in QA or QV within the pharmaceutical or biotechnology industry, particularly in aseptic filling and commissioning/qualification activities

Job Summary

  • The role ensures project performance aligns with Roche Standards, Good Practices, and regulatory requirements including Annex 1 and GAMP 5.
  • Candidates must possess at least 7 years of experience in pharmaceutical quality assurance with specific expertise in aseptic filling and new facility startups.
  • Roche fosters a culture of personal expression and genuine connections where every voice matters in the mission to prevent, stop, and cure diseases.

Matching Summary

Match Score: 85

Roche is seeking a Qv Lead for its Biologics division in Shanghai, China, to ensure projects comply with corporate and regulatory standards. The role requires extensive experience in QA or QV within the pharmaceutical or biotechnology industry, particularly in aseptic filling and commissioning/qualification activities.

Skills & Requirements

Must-have

  • 7 years pharmaceutical QA or QV experience
  • Aseptic filling facility experience required
  • New DP facility startup readiness
  • GMP standards knowledge ISO EN ICH FDA ISPE
  • Commissioning qualification lifecycle URS IQ OQ PQ

Nice-to-have

  • Auditor training certification advantageous
  • Multinational company background preferred
  • Risk-based approach to validation
  • Strong diplomatic communication skills
  • Process improvement recommendations capability

Key Requirements

  • Degree in pharmaceutical sciences or related discipline
  • Minimum 7 years QA/QV experience in pharma/biotech
  • Fluent English communication skills required
  • Experience with C&Q strategy execution and CSV
  • Knowledge of Dragon project phase regulations

Work Rights

Not specified

Tailored Resume

Cover Letter