Director Quality / Qualified Person (QP) (m/f/d)

About PAION Pharma

• 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.

• 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.

• 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.