Qualified Person / Sachkundige Person (m/w/d)

Roche Pharma AG

Grenzach, , Germany
Certification of global pharmaceuticals
Decision making on batch release
Compliance with eu pharmaceutical regulations
The role involves centralized, cross-border work for the entire EU, contributing decisively to the quality-compliant supply of innovative medicines to patients

Job Summary

  • The role involves centralized, cross-border work for the entire EU, contributing decisively to the quality-compliant supply of innovative medicines to patients.
  • Responsibilities include certification of globally manufactured medicines, decision making on batch usage, active quality system development, and participation in global audits.
  • Roche fosters a culture of personal expression, open dialogue, and genuine connections, valuing each employee to thrive personally and professionally.

Matching Summary

The role involves centralized, cross-border work for the entire EU, contributing decisively to the quality-compliant supply of innovative medicines to patients.

Skills & Requirements

Must-have

  • Certification of global pharmaceuticals
  • Decision making on batch release
  • Compliance with EU pharmaceutical regulations
  • Conducting global quality audits
  • Project leadership and management
  • International stakeholder networking

Nice-to-have

  • Experience with Advanced Therapy Medicinal Products
  • Teamwork in agile and self-organized teams
  • Resilience and strong communication skills
  • Training and mentoring pharmacy interns
  • Innovative and goal-oriented work style

Key Requirements

  • Qualified Person according to § 15 AMG
  • Very good knowledge of EU pharmaceutical regulations
  • Experience as QP in novel therapies (ATMP) preferred
  • Fluent German and English language skills

Work Rights

Not specified

Tailored Resume

Cover Letter