Quality Manager (m / f / d)

About us HEC Pharm GmbH is a major supplier of generic medicinal products to the German pharmaceutical market. HEC Pharm GmbH is a subsidiary of Sunshine Lake Pharma Co., L.T.D, China and has been active in Germany for 14 years. Both companies are organizationally part of the HEC Pharm Group, a multi-billion-dollar company with 20,000 employees operating in China, USA, Germany, UK, Japan, and Korea. Homepage : https : / / hecpharm.de / To strengthen our Regulatory Affairs and Quality Department, we are seeking a quality manager to work closely with the department head. This role includes both technical and administrative tasks and offers insights into pharmaceutical regulatory processes in a dynamic and international environment. Your responsibilities : Provide administrative and operational support to the department head, including meeting coordination, documentation follow-up, and communication support; Establishment and maintenance of GDP (Good Distribution Practice) system; Maintain documents, records, and meta-information in our document management system; Read and follow regulations, directives, German laws, guidelines, and internal SOPs; Preparation for and participation in audits and inspections; Prepare documents for serialization of products, products tracking, mockups, management of products release and pharmacovigilance in the EU; Collect technical information for regulated processes and implement CAPAs. Your qualifications : At least a bachelor degree from a university (preferably listed in the top 500 of Times Higher Education ranking) in a relevant scientific field (Please send a copy of your diploma with courses and grades); Additional qualifications, such as graduate university degree, regulatory and quality trainings, and experience in the pharma industry are of advantage; Familiarity with EU GMP / GDP guidelines and document management systems; Good reading and writing skills, in particular for regulatory and technical texts; High degree of analytical thinking, interest in regulatory affairs and quality, and attention to details; Good communication skills and willingness to put your team above your own personal interests; High level of proficiency in English language, good German (at least B2 level), additional knowledge of Chinese is a plus. We offer A responsible position in an international pharmaceutical company with offices in Germany and UK; Start-up atmosphere with flat hierarchies and short decision-making paths; Flexible working hours and the option to work from home; A dynamic mix of technical and administrative tasks in the field of Regulatory Affairs and Quality; A supportive, diverse, and collaborative team culture; Opportunities for individual development and insights into European regulatory processes. Contact Ms. Susie Lue [email protected]