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