ATMP Qualified Person Leader

Posted 26 January 2023
Job type Permanent
Contact NameDuncan Johnston

Job description

QP ATMPs - Germany - Competitive Package

BioTalent are currently supporting a leading Global Biopharmaceutical organization with this position supporting the Cell & Gene therapy storage and distribution facility. They are in search for a QP to focus on the release/certification of clinical investigational medicinal products.

  • Approval decision for IMPs.
  • Conducting audits.
  • Review of manufacturing documents and validation documents.
  • Supervision of customer projects with direct contact with authorities.
  • Responsibility for the decision on the use of drug batches for clinical trials in accordance with AMG and EU Annex 13 and 16.
  • Approval as a pharmacist and expertise according to § 15 AMG.
  • QP according to German Medicines Act (§ 14 AMG, QP according to Directive 2001/83/EU)
  • Practical experience to pharmaceutical manufacturing.
  • Fluent in German and English.
This is an excellent opportunity to get involved in a global leader that produces lifesaving products whilst working at the forefront of science with a strong culture of collaboration. It will give you an play a critical role in Cell & Gene activities on the facility.

Please apply / email your resume with a convenient time to speak to or call directly via +41 41 561 53 76 to have a confidential discussion about this opportunity.