With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients. **Accountabilities:** + Collect, submit & coordinate Corporate CRC + Maintain and manage the change control system and ensure the change management is under control. + Evaluate and coordinate the change project to ensure the project execution complied with plan and regulation + Maintain and manage the change control system and ensure the change management is under control. + Evaluate and coordinate the change project to ensure the project execution complied with plan and regulation + Follow up regulations including Chinese GMP，EU，TGA，PIC/S, ICH etc. + Communicate with channel to maintain with authority，association etc. + Maintain license and certificate in fully compliance status. + Review and collect updates of regulations/guidelines such as NMPA, ICH, PIC/S, etc. and conduct gap analysis timely. + Conduct gap analyses of the regulatory to ensure comply with regulatory requirement; + Ensue registration documents and CMC documents are right first time and well maintained. + Prepare, receive and response to corrective measures of external audits, maintain and optimize and external audit process to continuously improve the effectiveness and efficiency of quality management **Requirements** + Degree: Master and above + Major: Pharmacy, chemical and life science related + Adaptability to change, willingness to share and learn + Good analytical and scientific thinking and problem solving skills + Result oriented All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.