北京招聘

Job Description:

    

? Provide guidance and direction regarding packaging site manufacturing operations to Quality to project teams

    

? Lead Quality focused meetings between CMOs, partners, and BeiGene

    

? Provide Quality support for batch disposition of packaged and labeled products

    

? Drive, lead and troubleshoot quality investigations at CMOs and logistics providers to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions

    

? Provide Quality guidance and support for investigations and change controls

    

? Provide support for process performance qualification activities including document review and approval

    

? Advise on Quality Agreement content and support Quality Agreement implementation and updates

    

? Ensure CMOs are compliance ready for regulatory inspections and monitor progress during inspections. Provide audit/inspection support of CMO as needed.

    

? Perform audits, as needed

    

? Monitor performance metrics and drive continuous improvements of CMO and internal processes

    

? Assess and revise, as needed, SOPs for GMP Quality functions and identify opportunities to streamline systems and processes

    

? Support regulatory filings, as needed

    

? May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products

    

    

Requirements

    

? Bachelor of Science degree, in a related scientific discipline

    

? Minimum of 10 years pharmaceutical or biotechnology industry GMP experience in a quality and manufacturing function

    

? Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail

    

? Interacts with all levels of BeiGene employees including CMOs

    

? In-depth knowledge of GMPs (EU, US, CN, AU, JP)

    

? In-depth knowledge of Quality principles, concepts, industry practices and standards

    

? Excellent verbal, written and interpersonal communication skills

    

? Ability to work independently with scientific/technical personnel

    

? Knowledge of risk management tools a plus

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。