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

We are seeking a highly qualified and independent Qualified Person / Sachkundige Person to oversee and ensure the compliance of manufacturing and quality control activities at the site, in accordance with the applicable manufacturing authorization, EU GMP requirements, and German regulatory requirements.

In this role, the Qualified Person will independently supervise manufacturing processes and control testing activities, acting in compliance with the applicable provisions of Directive 2001/83/EC, EU GMP, the German Medicinal Products Act — Arzneimittelgesetz, AMG, and the German Ordinance on the Manufacture of Medicinal Products and Active Substances — Arzneimittel- und Wirkstoffherstellungsverordnung, AMWHV, as amended. The role is critical in ensuring that medicinal products meet the required standards of quality, safety, and regulatory compliance.

Working closely with the Site Quality Head and Site Manager, the successful candidate will support the effective implementation, monitoring, and continuous maintenance of a GMP-compliant Quality Management System. This includes ensuring adherence to German medicines legislation, applicable EU and national regulations, internal ADACAP quality standards, approved product quality requirements, and site SOPs.

As part of the Quality Assurance function, the role will provide both operational and strategic support for GMP-related activities, helping to identify, manage, and resolve quality issues while promoting a culture of compliance, accountability, and continuous improvement across the site.