• Maintain & manage quality system (QS) elements to enable quality oversight, quality oversight to GMP documentations, GMP trainings and corresponding validated electronic systems such as but not limited to IDEA for documents, LOS for training, etc. Build up learning capability of the Biopharma site via establish structured and stepwise training program to applicable regulations as well process knowledge.
• Facilitate and enable good relationships with Health Authorities, Industry Associations, national labs, etc.
• Maintain and improve QS by being proactively identify system or individual issues and/or by supporting corporate, internal, client and authority audits/inspections.
• Execute QS scientist tasks according to the agreed upon plan and time-line to ascertain the achievement of high quality standard.
• Be responsible for the training program management in BioChina via Role as local LBA back up for training system (LOS)
• Support to establish the annual GMP training plan as per training needs collected.
• Lead the design and compilation of annual cGMP training materials and address the trainings to ensure that quality system provide required cGMP (on-board, refresh) training course to staffs.
• Analyze the current training approach suitability and effectiveness,collect training needs and design corresponding training courses to satisfy compliance enhancement. Lead to build up learning capability of the Biopharma site via establishing well structured and stepwise training program in terms of regulations, global standards and guidelines, process knowledge, etc.
• Support QMR expectation to training management.
• Sourcing applicable and valuable outsourced training/workshop/seminars etc., and screen the promotion to the site level and department level as needed, establish knowledge sharing platform as appropriate.
• Supporting and managing the quality management systems and assuring compliance with regulations for global inspections readiness including China, USA, EU and RoW.
• Support QS team to host "audit/inspection" by authority and client. (e.g. War room management to support timely preparation of inspection/audit requests, moderation during inspections/audits, support/lead the process of response procedure as needed, support SMEs to fulfill inspection/audit requests until mitigation action execution,etc. )
• Support Quality system lead to execute the site inspection readiness activities including but not limited to
• Familiarity of regulations and regulatory procedures
• Delivery of trainings to SMEs/inspection preparation team members, or management team (local SLT, global management) as needed
• Realization of agreed input/output for the inspection readiness project charter
• Detailed inspection readiness activities, such as Gap assessment, preparation activities execution and follow up
• Lead and maintain close interaction with local Health Authorities, Industry Associations, national labs, etc. as per driven by business needs, to facilitate and establish good relationships with these external stakeholders.
• Sensitivity to applicable regulatory trend, inspection hot topics, HA observation categories breakdowns, Biopharma network deficiencies noted during HA inspections, incorporate into QS and compliance improvement initiative.
• Support Bio network

• Education/Degree Requirements: Bachelor's degree required in a relevant discipline, advance degree is preferred
• Major: Focus on pharmaceutical/bio pharmaceutical, biotechnology, chemistry/biochemistry, etc
• Language skills & proficiency: Mandarin must, fluent in English, oral and aural, read and compile ability to satisfy working needs
• At least 5-7 years QA working experience in GxP system as well as experience in pharmaceutical industry.
• Profound knowledge and understanding of regulatory QS requirements as governed by cGMP and regulatory agencies (NMPA, USFDA, EMA, etc); Knowledge of cGMP regulatory compliance standards and regulatory filings
• Fruitful experience in Quality management department in relevant industries.
• Excellent communication skills, persistence, commitment.
• Rapid learning ability, high level of energy and self-motivation.
• Organized analytical thinker and attention to detail.
• Inter-cultural competence, be culturally sensitive and diplomatic.
• Ability to work independently, bear team cooperation spirit, be flexible and agile.
• Proven ability to work creatively and analytically in a problem-solving and process-oriented environment. Proven ability to work in a collaborative, team-based environment dependent upon effective teamwork to achieve goals and company objectives.
• Experienced in using office application software (MS-Word, MS-Excel, MS-Project, MS Power Point, MS-Outlook).

上班地址：张江高科龙东大道1010号