北京招聘

Description:

• Provide Quality guidance of cGMP external manufacturing operations (CMO)
• Provide guidance and direction regarding manufacturing Quality to project teams
• Lead Quality focused meetings between CMOs, partners, and BeiGene
• Provide Quality support for batch disposition of drug substance, drug product and finished product
• Drive, lead and troubleshoot quality investigations at CMOs 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
• 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
• Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail
• Interacts with all levels of BeiGene employees including CMOs

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。