**General Description:** The incumbent will report to the Associate Director, Drug Product Commercial Small Molecule, External Supply Quality and be responsible for supporting activities relating to BeiGene’s external GMP operations in the US as well as internal BeiGene GMP processes, ensuring procedures and systems are in place to support BeiGene’s commercial products. The incumbent will provide support in ensuring that commercial products are manufactured, packed, labelled, distributed, and controlled in accordance with regulatory expectations and applicable quality standards. **Essential Functions of the job:** + Batch Record review and release preparation of commercial APIs, primary packed products and finished products manufactured by contract manufacturers on behalf of BeiGene. + Follow up on and asses CMO deviations and other issues + Assess change controls, perform change actions and follow up on change status + Monitor CMO performance metrics + Close collaboration with BeiGene's Manufacturing, Supply Chain and Regulatory teams + Support the update of Quality Agreements with BeiGene’s external partners + Lead or support quality document updates. + Perform other tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines and provide support to cross-functional teams when needed. **Experience:** + At least 4 years pharmaceutical or biotechnology industry experience. + GMP experience in a quality function. + Commercial QA experience preferred. **Core Knowledge and Skill Requirements** **:** + Knowledge of Quality principles, concepts, industry practices and standards. + Working Knowledge and experience with 21CFR210, 21CFR211, ICHQ7 as well as international regulations. + Excellent verbal, written and interpersonal communication skills. + Ability to work independently with scientific/technical personnel. + Apply principles of logical and scientific thinking to a wide range of intellectual and practical problems. + Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail. + Spoken/Written fluency in English required **Computer Skills:** + PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) + Experience with electronic quality management systems preferred + Ability to work on a computer for extended periods of time **Education Required:** Bachelor’s degree in science or combination of education and equivalent work experience **Travel:** + May travel approximately 5 - 10% All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.