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

Salary Range: $0.00 - $0.00   Job Description Summary #LI-Onsite Location: Halle, Germany This role is based in Halle, Germany. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. 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.   Job Description Major Accountabilities: • Certify and release medicinal product batches, ensuring manufacturing and testing are performed in compliance with applicable laws, EU GMP requirements, the manufacturing authorization, and Marketing Authorization conditions. • Ensure batch documentation and records are complete, accurate, properly stored, and available for inspection or upon request by the relevant German competent authorities. • Assess and release manufactured medicinal products in accordance with German national legislation, EU GMP requirements, and the responsibilities of the Qualified Person / Sachkundige Person. • Collaborate with Quality Control and Production teams to support batch-related activities and ensure smooth, compliant production operations. • Review, support, and approve quality processes including deviations, complaints, change controls, CAPAs, and related investigations. • Immediately escalate any significant quality irregularities identified in marketed products to site management and, where required, to the relevant German competent authority in accordance with applicable reporting obligations. • Partner with functional leaders to maintain, monitor, and continuously improve an effective GMP-compliant Quality Management System. • Identify and propose technological, procedural, and organizational improvements to enhance quality, productivity, cost efficiency, and resource optimization. Essential Requirements: • Degree in Pharmacy, Chemistry, Pharmaceutical Chemistry, Biology, Human or Veterinary Medicine, or another relevant scientific discipline meeting the requirements for a Qualified Person / Sachkundige Person under applicable German legislation. • Eligibility to act as a Qualified Person / Sachkundige Person in Germany , including compliance with the qualification and practical experience requirements under the German Medicinal Products Act — AMG , in particular the applicable requirements for sachkundig