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.

• 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.

• 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.

• 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.

Ms. Susie Lue

[email protected]