**THE POSITION** _Support the establishment, continuous improvement, and maintenance of the Quality Management System at Boehringer Ingelheim Korea by ensuring compliance with external (e.g., Good Distribution Practice, Good Storage Practice, Korean regulations) and internal Boehringer Ingelheim requirements_ **Tasks & responsibilities** + **_Support Quality Management System of Boehringer Ingelheim Korea Human Pharma and Animal Health._** _- Support the management of local quality operation/activities to ensure it is compliant to applicable regulatory_ _and Boehringer Ingelheim requirements._ _- Ensuring the set up and maintenance of a document management system for local SOPs/ Working Instructions._ _- Maintaining a library of all the relevant regulations and guidelines related to commercial product supply and_ _Distribution._ _- Supporting Quality System, which includes Deviation, Complaint, Change Control, Risk, CAPA Management._ + **_Support Audit Management, which includes self-inspections, internal audits and authority inspections._** _- Ensuring regular self- inspections at Korea to drive the continuous improvement program and to ensure_ _readiness for Corporate or Korean authority inspections._ _- Managing audits by Corporate or inspections by local Authorities in respect to quality compliance._ _- Ensuring adequate CAPA plans are established and tracked for audit/inspection completion._ + **_Support external 3_** **_rd_** **_party Management._** _- Ensuring quality and regulatory compliance of products/ services which are out-sourced to external parties._ _- Supporting quality audits at local suppliers and external parties (qualification and regular audit)._ _- Acting as first escalation to resolve quality issues from external parties._ + **_Release commercial batch as back up of authorized batch releasing person for Boehringer Ingelheim Korea Human Pharma._** _- Supporting Batch disposition (release/ reject) for distribution of human pharma product in accordance with_ _Korean regulation as a back up of authorized batch releasing person._ _- Supporting product launch which includes analytical method transfer and preparation of quality documents._ _- Ensuring correct handling and storage of market returns, promotional and retention/reserve samples._ **Requirements** _· Korean Pharmacist License (Required)_ _· Fluent in Korean and English (reading, writing, and speaking)_ _· Minimum 2 years of quality or regulatory function experience preferred_ _· Able to travel domestically as required_ _· Ability to develop and maintain constructive relationships internally and externally_ _· Commitment to continuous improvement_ 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.