Your tasks
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.
As Qualified Person (QP)
- 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.
Your profile
- Minimum 5 years of experience in Quality Assurance within a GMP-regulated environment.
- Qualified Person in accordance with §15 AMG with proven experience in batch certification and product release.
- Strong knowledge of EU GMP/GDP requirements and Pharmaceutical Quality Systems.
- Demonstrated experience leading quality systems, regulatory inspections and customer audits.
- Proven leadership, communication and stakeholder management skills in a cross-functional environment.
- Proficient in Microsoft Office, electronic Quality Management Systems and other relevant business applications.
Why us?
- 30 days vacation (full time) and additional benefits.
- Short communication channels, open doors and helpful, committed colleagues.
- Flexible working hours with partial home office (max. 2 days/week).
- Modern office building with underground parking spaces in a location close to the A44 motorway.
PAION contact details
We look forward to receiving your application preferably by email, at recruiting@paion.com.
If you have any questions, you can send us an email to HR@paion.com.
If you have any questions, you can send us an email to HR@paion.com.
For further information please visit our website: www.paionpharma.com
About us
PAION Pharma GmbH, headquartered in Aachen, Germany, is a specialty pharmaceutical company in the field of anaesthesia and critical care specialising in innovative pharmaceuticals for use in outpatient clinics and hospitals.
PAION Pharma GmbH is part of the Humanwelll Healthcare Group.
www.paionpharma.com
Director Quality / Qualified Person (QP) (m/f/d) in Aachen Arbeitgeber: PAION Pharma
PAION Pharma GmbH ist ein hervorragender Arbeitgeber, der Ihnen die Möglichkeit bietet, in einem dynamischen und internationalen Team zu arbeiten, während Sie an innovativen Technologien im Bereich der IT-Infrastruktur mitwirken. Mit 30 Tagen Urlaub, flexiblen Arbeitszeiten und der Option auf Home-Office fördern wir eine ausgewogene Work-Life-Balance und bieten Ihnen zahlreiche Möglichkeiten zur fachlichen Weiterentwicklung in einem anspruchsvollen Umfeld der Pharmaindustrie.
