Senior Quality Assurance Manager / Qualified Person (m/w/d)

Roche UK

Mannheim, Germany
Gmp-konforme arzneimittelchargenfreigabe
Sicherstellung regulatorischer vorgaben
Bearbeitung komplexer unplanned events
As a Senior Quality Assurance Manager / Qualified Person, you will actively promote the implementation of our Lean-Mindset culture and ensure the harmonization and continuous improvement of processes

Job Summary

  • As a Senior Quality Assurance Manager / Qualified Person, you will actively promote the implementation of our Lean-Mindset culture and ensure the harmonization and continuous improvement of processes.
  • You will be responsible for the GMP-compliant and timely release of drug batches, considering legal, regulatory, and internal Roche requirements, and will act as the Qualified Person according to §14 AMG.
  • Roche offers a comprehensive benefits package including a long-term account, a pension plan, and support for work-life balance, with attractive cultural and leisure offerings in Mannheim.

Matching Summary

As a Senior Quality Assurance Manager / Qualified Person, you will actively promote the implementation of our Lean-Mindset culture and ensure the harmonization and continuous improvement of processes.

Skills & Requirements

Must-have

  • GMP-konforme Arzneimittelchargenfreigabe
  • Sicherstellung regulatorischer Vorgaben
  • Bearbeitung komplexer Unplanned Events
  • Quality Oversight Konzept
  • Batch Confirmation
  • Arzneimittelrechtliche Voraussetzungen prüfen

Nice-to-have

  • Lean-Mindset Kultur fördern
  • Teamplayer mit offenes Ohr
  • Positive, integere Persönlichkeit
  • Can-Do-Einstellung
  • Unternehmerische Denkweise

Key Requirements

  • 7-10 years of experience in Pharma QA/Manufacturing
  • Qualified Person competencies (§14 AMG)
  • Completed Pharmacy degree and Pharmacist license
  • Excellent GMP knowledge
  • Strong national/international drug law knowledge
  • Experience with international interfaces
  • Excellent German and English communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter