**_General_** **_Description:_** Manages and supports the analytical development and QC activities at designated Contract Manufacturing Organizations. This includes working with CMO Quality as a QC representative to review and approve technical documents such as stability reports, analytical procedures and analytical record reviews. Manage and support product development and commercial global launches by serving as analytical/QC SME in the areas of method qualification/validation/transfer, specification development and management, stability studies, shelf-life updates and associated change control. Support global projects improve analytical/QC related systems and processes. **_Essential Functions of the_** **_job_** **_:_** + Perform QC review on specifications, analytical record, CoAs, stability protocols and reports, and other technical documents. + Manage stability studies at CMOs + Manage methods transfer and methods validation activities to CMOs, including transfer/validation strategy and approval of protocols and reports. + Maintain proactive engagement with QC counterpart at the CMO. + Support CMC activities at CMO as necessary. + Provide QC oversight on assigned development and commercial projects. + Ensure current projects are in compliance with BeOne SOPs. + Support Global Quality Systems and Global Standards implementation. + Assess and revise, as needed, SOPs for GMP Quality functions and identify opportunities to streamline systems and processes. + Perform duties as assigned to ensure compliance to global and local regulations. **_Core Competencies, Knowledge and Skill_** **_Requirements_** + 5+ years working experience and 2 years team management experience in an FDA-regulated pharmaceutical company. + Expert with pharmaceutical analytical and microbial testing and related equipment/instrument. + Familiar with the USP/EP and the cGMP/EU GMP. + Wide knowledge of analytical methods and electronic systems. + Strong leadership/team management skills and experience. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical and problem-solving ability. + Excellent project management skills. + Hands-on approach, with a ‘can do’ attitude. + Ability to prioritize, demonstrating good time management skills. + Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. + Self-motivated, with the ability to work proactively using own initiative. + Committed to learning and development. **_Significant_** **_Contacts_** + Interacts with all levels of BeiGene employees including CMOs and suppliers. **Project Management** - Communicates changes and progress; Completes projects on time and budget. **Computer** **Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint) **Other** **Qualifications:** 5+ years' experience with Bachelor of Arts, or 4+ years with above degree in a related scientific discipline. 2+ years with PHD. **Travel:** + Must be willing to travel approximately 5% + Ability to work on a computer for extended periods of time 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.