Job Responsibilities

Managing the routine operation of the QC team to ensure business delivery at the right quality, cost, and speed Overseeing several sub-teams such as sample management, reference management, regulatory management, and QC instrument and equipment management Leading the team to comply with internal requirements in all aspects through end-to-end quality control system oversight Ensuring all activities in the QC team are performed in compliance with cGMP, data integrity, and EHS requirements Overseeing the training, evaluation, and management of the staff in the QC lab, including coaching, developing, and supporting them to reach their full potential Being responsible for GMP audits from regulatory authorities and clients, responding to audit reports, and creating CAPAs

Job Requirements

Bachelor’s degree or above in pharmacy, chemistry, biochemistry, analytical chemistry, or other related disciplines Minimum of 7 years of working experience in the biotech or biopharma industry A good understanding of the overall drug development process A thorough understanding of the principles and management of cGMP compliance, and a strong quality mindset Comprehensive knowledge of FDA, EMA, NMPA, ICH, WHO technical guidelines, and USP, Eur.P, ChP pharmacopoeias Comprehensive knowledge of IND/IMPD, NDA, and ANDA filing

Required Languages

English