[Huons Global Co., Ltd.] Hiring experienced professionals for the QA team

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✨Job Responsibilities - Recruiting experienced personnel for the Huons Global R&D QA team - Designing the integrated quality management system (QMS) framework for the group and establishing standard guidelines - Overseeing the introduction and operation of the eQMS system - Integrating SOPs across affiliates and establishing/spreading an R&D/manufacturing risk management model based on ICH guidelines - Establishing and executing the annual Self-inspection plan - Advancing the verification system for research notebook integrity and Data Integrity - Final review of CMC materials for submission of marketing authorization applications (NDA/BLA) - Establishing inspection strategies for MFDS and overseas regulatory authorities and overseeing inspections - Spreading a quality culture through communication with affiliated R&D/manufacturing organizations and external outsourcing partners - Managing the newly established team organization ✅Qualifications - Bachelor’s degree or higher from an accredited domestic or international university - Experience in R&D QA or manufacturing (GMP) QA in the pharmaceutical or biotech industry - Experience overseeing CMC quality assurance and external CMO management for recombinant protein or biopharmaceutical products - Audit and verification capabilities based on Data Integrity guidelines - Experience leading a small team or holding a leadership role such as a section head or team leader - No disqualifying issues for overseas travel or visa issuance 💖Preferred Qualifications - Specialized knowledge of global regulatory guidelines (ICH, biopharma GMP, GLP, etc.) and the ability to apply them in practice - Strong communication skills to coordinate opinions and drive collaboration among multiple stakeholders such as development companies, manufacturing affiliates, and external CMOs - Proficient in business English - Experience leading eQMS implementation and enterprise-wide quality system enhancement at global big pharma or large biotech companies - Experience reviewing/approving QA for NDA/BLA filings and CMC documents (CTD) for recombinant protein therapeutics - Experience overseeing inspection response for MFDS and overseas regulatory authorities (FDA, EMA, etc.) and completing CAPAs for findings - Preference for eligible national merit recipients and persons with disabilities - Preference for women with career interruptions 🏠Work Location - 9th Floor, Building A, 17, Changup-ro, Sujeong-gu, Seongnam-si, Gyeonggi-do - Seongnam Sujeong Pangyo Office Building ⚡️Hiring Process - Document screening > Personality test > 1st interview (practical staff) > 2nd interview (management) > Pre-employment medical checkup > Joining 👉Recruitment Period/Method - Application period: until 2026-11-29 - Application method: Not specified in the posting 📋Other - May close early once hiring is completed - If the information in the application form differs from the facts, the offer may be revoked - If deemed suitable, a separate recruitment process may proceed even before the posting closes