Qualification, Validation and Quality Systems Manager (m/f/d)

Planning, coordination and implementation of qualification and validation projects for plants, equipment, manufacturing processes, analytical methods and computer-assisted systems (CSV) according to GMP requirements Creation, testing and maintenance of qualification and validation documentation, including risk analyses, plans, protocols, reports and quality-relevant documents Ensuring and regular review of the qualified or validated state of plants, processes, laboratory and software systems Accompanying the procurement, introduction and GMP-compliant commissioning of new plants, equipment and laboratory systems Participation in the establishment, introduction and continuous development of an efficient and scalable quality management system Digitization and optimization of laboratory, qualification and quality processes through the further development and introduction of LIMS, eQMS and device and test equipment management systems Identification, evaluation and implementation of innovative automation and AI-based solutions for improving efficiency, improving data quality and sustainable optimization of quality processes

Successfully completed technical, scientific, pharmaceutical or comparable university studies Multiannual professional experience in a GMP-regulated pharmaceutical, biotechnological, medical or radiopharmaceutical environment Knowledge gained in the qualification of equipment and equipment and in the validation of processes, analytical methods and/or computer-assisted systems (CSV) Good knowledge of relevant GMP requirements; Experiences with quality management systems and ideal knowledge of ISO 9001 and/or ISO 13485 High IT and digitalization affinity as well as interest in the introduction and further development of LIMS, eQMS, database, automation and AI solutions; Experiences with laboratory or quality systems are advantageous Self-employed, structured and solution-oriented mode of operation, pronounced communication and team capacity, high self-initiative and readiness for continuous professional and regulatory further education Very good knowledge of German and English in word and writing

Flexibility: design of working hours through mobile work, flexible working hours and decent-related paid allowances (e.g. moving or dates for cancer provision) for an optimal work-life balance Family-friendliness: support in the reconciliation of family and profession, through paid allowances for family events, such as child-hospitable days, family start time or your own wedding Compensation package: Attractive remuneration as well as asset-effective services and property vouchers or JobTicket Holiday and recreation time: 30 days holiday for regular rest and to recharge energy Work comfort: pleasant work environment without large-scale office and ergonomic tables and chairs for comfort at work Stability & Perspective: Safe workplace in an established company with long-term prospects and development opportunities Health promotion: occupational health management with health insurance Variety of mobility: JobTicket, e-bike leasing, good ÖPNV connection and parking opportunities for sustainable mobility