About PAION Pharma
We are a specialized pharmaceutical company headquartered in Aachen, Germany and part of the Humanwell Healthcare Group. We focus on innovative solutions in anesthesiology, intensive care, and infectious diseases, with a strong emphasis on hospital-based treatments that support healthcare professionals in delivering high-quality patient care.
As Director Quality, you support the Vice President Quality in leading the Quality organization and ensuring an effective Pharmaceutical Quality System that meets applicable regulatory, customer and business requirements. In addition, you act as Qualified Person in accordance with EU GMP and national requirements
Key responsibilities and tasks
As Director Quality
- Ensure the effectiveness, compliance and continuous improvement of the Pharmaceutical Quality System.
- Drive quality strategy, operational excellence and cross-functional quality improvement initiatives.
- Ensure compliance with applicable GxP regulations and maintain required licenses and authorizations.
- Oversee key quality systems, including quality procedures, deviations, CAPAs, change controls, complaints and quality risk management.
- Monitor quality performance, inspection readiness and compliance across the organization.
- Support and represent Quality during regulatory inspections, customer audits and interactions with health authorities.
- Perform batch certification and release of medicinal products in accordance with EU GMP, Annex 16 and applicable national legislation.
- Ensure that all legal and GMP requirements for batch certification are fulfilled prior to product release.
- Review and evaluate batch documentation and release-relevant quality records, including deviations, OOS/OOT investigations and change controls.
- Maintain the release register and product disposition status.
- Ensure appropriate product knowledge prior to certification of new or unfamiliar products.
- Maintain current knowledge of applicable regulatory, scientific and technical requirements relevant to QP responsibilities.