(associate) Manager, Qs & Compliance, Biologics

Roche

Unknown
Quality management system compliance
Regulatory inspections management
Risk management expertise
At Roche you can show up as yourself, embraced for the unique qualities you bring

Job Summary

  • At Roche you can show up as yourself, embraced for the unique qualities you bring.
  • The role involves providing strategic direction and managing execution of regulatory inspections, internal and external audits, and paper-based inspections.
  • Roche empowers each other to explore new possibilities, foster creativity, and keep ambitions high to deliver life-changing healthcare solutions.

Matching Summary

At Roche you can show up as yourself, embraced for the unique qualities you bring.

Skills & Requirements

Must-have

  • Quality management system compliance
  • Regulatory inspections management
  • Risk management expertise
  • Aseptic filling experience
  • FDA/EU cGMP knowledge
  • Stakeholder management skills
  • New facility startup readiness

Nice-to-have

  • Strong problem-solving abilities
  • Critical thinking skills
  • Agile and flexible mindset
  • Effective and diplomatic communication
  • Training program development
  • Leadership competencies
  • Team collaboration

Key Requirements

  • Degree in pharmaceutical sciences or related discipline
  • Minimum 7 years experience in pharmaceutical or biotechnology quality assurance
  • Experience managing regulatory inspections with Global Health Authorities
  • Fluent English communication skills
  • Experience with SAP, Veeva, Orca tools
  • Knowledge of ICH guidelines
  • Experience in new drug product facility projects

Work Rights

Not specified

Tailored Resume

Cover Letter