Head of Quality Assurance GMP Compliance (m/f/d)

Head of Quality Assurance + GMP Compliance (m/w/d) Focus: QMS installation according to ATMP guidelines (optional QP) PROVIREX Genome Editing Therapies GmbH develops innovative therapies in the field of genome editing to combat retroviral diseases. In our S3** certified production rooms, we also use our know-how for the production of CAR‐T cell therapies under the brand S3LTEC. Our team combines scientific excellence with high self-responsibility and short decision-making in an open, value-adding cooperation. As an emerging biotech company, we are now laying the foundation for the next step in growth and now offer you the opportunity to start as Head of Quality Assurance + GMP Compliance (m/w/d). Your role + tasks | versatile In this key position, you take responsibility for Quality Assurance and GMP compliance. You complete the development of our quality management system and ensure that processes in everyday life are not only regulatory, but also practical - with a view to the production of clinical trials according to ATMP guidelines. You work closely with production line and quality control, combine the qualification and validation of the new production plant and the QC laboratory and are central: contact person:in the government office of Hamburg in the context of obtaining the production permit. Optionally, if the conditions are met, you also assume the role of the expert (QP) in accordance with §15 AMG. You design and control the essential QA processes end-to-end, among others: development of 'liveable' QM processes and continuous development of QMS (GMP/ATMP) Creation and revision of SOPs and Formsheets in existing eQMS Control of deviations, CAPA and change management as well as training and training management Construction of a transparent system for periodic testing of qualification and validation documents (production + equipment, QC laboratory) Monitoring the GMP-compliant implementation of gene therapy methods including Validation/method validation activities Compilation and testing of batch documentation (production + QC) Authority communication as an interface to the government office Hamburg Optional (QP): Release and placing on the market of test samples/products according to regulatory requirements Your profile | convincing You are a solution-oriented pioneer personality that wants to develop and shape new things, take responsibility, make decisions and enjoy working in an interdisciplinary team. Natural science studies (e.g. biotechnology, biology, pharmacy, chemistry) Multiannual experience in quality management under GMP regulations, ideally in the life sciences/biopharma environment (cell/gene therapy of advantage, no need) Routine in the implementation of QMS core processes (SOP/eQMS, CAPA/CC, training management, docu test) Finded practice in audit/inspection experience For the QP option: Compliance with the criteria according to §15 AMG (including relevant requirements according to paragraph 3a, production and testing of medicinal products for novel therapies) Structure, care and sense of responsibility as well as strong team skills Leadership and project management competence, coupled with pragmatic implementation strength Curiosity and a clear, solution-oriented communication style Our offer | valuable: Innovative Biotech environment with a lot of development space Modern offices, laboratories and production areas in the Hamburger Westen (TechHub) Long-term full-time employment, flexible working hours and up to 2 days home office/week 30 days holiday/year, ÖPNV grant and regular team events Lead QUALITY. Enable PROGRESS. If you want to manage quality not only, we look forward to successfully networking you with our client PROVIREX. Send us your meaningful application documents with the identification number 109.770 preferably via our ISG career portal or via eMail to bewerbung.sommer@isg.com. See you soon! ISG Personalmanagement GmbH A-1010 Vienna, Universitätsring 14 Lena Sommer, M.A. @: bewerbung.sommer@isg.com