Director, Global GMP e-Systems

招聘人数：1 人 性别要求：不限性别 KEY ACCOUNTIBILITIES: Support a full spectrum of quality and Information Systems. Accountable for strategic technology planning/ road-mapping, operational run and building of new capabilities supporting the function globallyDrive the company’s digital transformation and integration of critical GMP applications in Quality management, Laboratory control, Documentation, Calibration and Maintenance. Work with GGeS Head and business stakeholders to develop short-term working plans and long-term sustainabilityActively define and run the annual GGeS project portfolio of quality / labs projects and oversight of long term run support of solutions implementedProvide direct management to GGeS work stream coordinating their activities, progress towards goals and career development Provide technical & program/project leadership to the project teams in all project phases (design, build, commissioning, validation, deployment to sites and operational support) as well as GGeS leadership oversight to the budget, schedule and staffing Working with GGeS Head, setup and lead strategic programs including digital labs, big data infrastructure and business Analysis program, guide and influence new business strategyDirect efforts of information systems integrators, vendors, internal or external IT teams to achieve successful executionEstablish and maintain intact GGeS infrastructure that supports manufacturing automation and information systems to attain the standard in security, operability and business continuityData management and system administration in accordance with WuXi procedures and compliance requirements; system owner of major GMP systems such as LabWare LIMS, Biovia ELN / LES, Waters Empower CDS, Agilent OpenLab ECM, Sparta TrackWise QMS, IBM Maximo EAM, MasterControl doc and training controlInitiate new projects by collaborating with project sponsors and business stakeholders to define scope, analyze requirements, evaluate feasibility, and determine project implementation plan Work with quality, validation, data integrity and business team to prepare systems and teams for regulatory inspection Lead or support Change Control, Risk Assessment, non-compliance investigation and reportingBuild positive team culture, with coaching, training, setup skill matrix to build a strong and agile GGeS team

REQUIREMENTS: Bachelor’s degree in Computer Science or related discipline is required with a minimum of 10 years of information system experienceMinimum of 6 years of experience in design and build and / or operational support of quality management and quality control in clinical and commercial manufacturingFamiliar with LIMS, ELN, TrackWise or similar, ERP/SAP or other areas of information systems supporting manufacturing business unit4 years of managerial experience directly managing people and /or leadership experience leading teams, projects, programs or directing the allocation of resourcesA broad range of experience across general IT, the infrastructure, operations and maintenanceTrack record of leading IT/OT integration, system deployment, work flow improvement, customized solution delivery in support of pharmaceutical/biologics manufacturing digitalization Working knowledge of enterprise business systems delivery, support and service ownership in the area of manufacturing, supply chain, quality, laboratory and engineeringStrong program leadership skills, client interfacing and resolution of business partner concerns, vendor contract management, validation, technical mentorship Working knowledge in cGMP, 21 CFR part 11 regulations, software development lifecycle and system validation
EDUCATION: Bachelor or above; MBA is a plus

OTHER SKILLS, ABILITIES & EXPERIENCE: Excellent oral and written communication skills, leadership ability and ethical judgment Ability to work collaboratively within team and with other departments Ability to work effectively with minimal supervisionHas CAN DO attitude to meet new challenge