Die Ophtapharm AG ist eine FDA/EU-GMP zertifizierte Produzentin im Pharmabereich (Ophthalmika). An unserem Produktionsstandort in Hettlingen bei Winterthur werden für internationale Märkte qualitativ hochstehende Produkte wie Augentropfen, -salben und -gele aseptisch produziert, abgefüllt und verpackt. To strengthen our team in Hettlingen, we are looking for a at the earliest possible date Manager Quality Control (m/w) 100 % Ihre Aufgaben Lead and manage the QC department, including Analytical Chemistry, and working closely with Microbiology and In-Process Control teams Ensure that all analytical testing is in compliance with cGMP, FDA regulations (21 CFR parts 210/211), and relevant Swiss and EU regulations for sterile drug manufacturing Oversee the sampling, testing and release of raw materials, in-process samples, and finished sterile ophthalmic products, ensuring timely and accurate results Develop, implement, and maintain robust analytical methods and testing procedures Drive continuous improvement initiatives within the QC laboratory to enhance efficiency, compliance, and data integrity Initiating and promoting automation and digitalization of processes Manage and mentor QC team members; provide technical and regulatory guidance, training, and performance management Represent your area of responsibility during Health Authority Inspections (e.g., FDA, Swissmedic) and Customer Audits Collaborate cross-functionally with Quality Assurance, Manufacturing, Regulatory Affairs, and R&D to support new product development and commercialization Lead investigations, root cause analysis, and CAPA for out-of-specification (OOX) results and other quality issues Ensure effective management of laboratory equipment, qualification, calibration, and maintenance in accordance with cGMP Maintain and ensure adherence to a comprehensive stability program for products marketed in the US Oversee preparation, review, and approval of QC-related SOPs, protocols, reports, and specifications Ihr Profil Advanced degree in Pharmacy, Chemistry, or related scientific field Minimum 10 years of experience in Quality Control, with at least 5 years in a leadership role within sterile pharmaceutical manufacturing Strong knowledge of FDA cGMP, USP, ICH guidelines, and EU GMP for sterile products Experience working in or with facilities exporting to the US pharmaceutical market ; prior involvement in successful FDA inspections is a must Hands-on experience with modern analytical instrumentation (e.g., HPLC, GC, UV-VIS, FTIR) Demonstrated leadership, decision-making, and project management skills Curious and interested in innovation and improvement Excellent communication skills as a point of contact across departments and functions Fluent in German & English Ihre Vorteile Dynamic environment with development opportunities Possibility of partially working remotely (20% max) Free parking and public transport within walking distance Above-average social benefits Arbeitsort Ophtapharm AG Riethofstrasse 1 8442 Hettlingen CH Haben Sie Fragen? HR Hettlingen, Human Resources, beantwortet Ihnen diese gerne. Tel: 41 52 304 12 36.