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

Roche Pharma AG

Grenzach, Germany
Not specified (likely in-office due to the nature of the role and location)
Sachkundige person qualification per § 15 amg
Deep knowledge of eu pharmaceutical regulations
Decision-making authority for batch releases
Roche Pharma AG is seeking a Qualified Person (m/w/d) based in Grenzach, Germany, to join their international quality assurance team. The role emphasizes collaborative decision-making and compliance within the European Union, focusing on the certification of innovative medicines for clinical studies

Job Summary

  • This role offers a centralized Qualified Person position within an international team in Grenzach, serving the entire European Union market.
  • The incumbent acts as a decision-maker with societal-wide authority over batch usage decisions and critical events like recalls.
  • Roche fosters a culture of personal expression and open dialogue where every voice matters in preventing, stopping, and curing diseases.

Matching Summary

Match Score: 85

Roche Pharma AG is seeking a Qualified Person (m/w/d) based in Grenzach, Germany, to join their international quality assurance team. The role emphasizes collaborative decision-making and compliance within the European Union, focusing on the certification of innovative medicines for clinical studies.

Skills & Requirements

Must-have

  • Sachkundige Person qualification per § 15 AMG
  • Deep knowledge of EU pharmaceutical regulations
  • Decision-making authority for batch releases
  • Experience with clinical trial preparations
  • Ability to lead global audits

Nice-to-have

  • Experience with Advanced Therapy Medicinal Products ATMP
  • Fluency in German and English negotiation
  • Resilience in agile self-organized teams
  • Networking skills with international stakeholders
  • Analytical skills for complex scenarios

Key Requirements

  • Sachkundige Person certification (§ 15 AMG)
  • Very good knowledge of EU drug regulations
  • Negotiation-safe German and English language skills
  • Teamwork and high level of self-responsibility

Work Rights

Not specified

Tailored Resume

Cover Letter