(associate) Manager, Qs & Compliance, Biologics

Roche UK

7+ years pharmaceutical quality experience
Aseptic filling process expertise
New facility startup readiness
The role involves mobilizing new sites from a quality and compliance perspective while developing resources for full QMS compliance

Job Summary

  • The role involves mobilizing new sites from a quality and compliance perspective while developing resources for full QMS compliance.
  • Candidates must possess in-depth knowledge of US and EU GxP requirements and experience managing interactions with global health authorities.
  • Roche fosters a culture of personal expression, open dialogue, and genuine connections where every voice matters.

Matching Summary

The role involves mobilizing new sites from a quality and compliance perspective while developing resources for full QMS compliance.

Skills & Requirements

Must-have

  • 7+ years pharmaceutical quality experience
  • Aseptic filling process expertise
  • New facility startup readiness
  • FDA/EU cGMP regulatory knowledge
  • Regulatory inspection management

Nice-to-have

  • Strong stakeholder management skills
  • Agile adaptability to changes
  • Diplomatic communication abilities
  • Cross-functional team collaboration
  • Strategic problem-solving mindset

Key Requirements

  • Degree in pharmaceutical sciences or related discipline
  • Minimum 7 years experience in QA/GMP
  • Experience with SAP, Veeva, or Orca tools
  • Fluent English communication skills required

Work Rights

Not specified

Tailored Resume

Cover Letter