南京招聘

Role:

SQM Regional Manager

In conjunction with the Global Head of SQM and the SQM business Process and systems manager will develop and deploy the following for 'direct materials'* throughout the supply chain and the regions.

·Develop and deploy strategy for the region

·Develop and deploy Policy, Quality Requirements/standards/directives and procedures

·Implement consistent processes and systems across the region and platform

·Develop metrics and Key Process Indicators (KPIs) for the region and platform in conjunction with SQM mangers

·Develop and manage quality system review metrics in conjunction with regional SQM managers

·Assign and deploy resources to achieve business and performance goals

·Drive Continuous Improvement objectives through End-to-End (E2E) process and metrics review


PERSONNEL RESPONSIBILITY

·Direct staff and operations within Supplier Quality in accordance with cGMP regulations and company standards :

­ Set business goals for each regional technology platform group

­ Establish and monitor performance measures and objectives for the groups

­ Optimize resources

·Participate in the development of strategic goals and objectives and maintain responsibility to cascade strategy down to regional organization

·Provide leadership and guidance to immediate staff managing the material and component suppliers

·Manage performance and development of direct reports to ensure achievement of organizational and department goals in a productive environment.

·Responsible for all aspects of employee development and performance according to the company guidelines

·Establish a communication plan within the SQM business process and systems team and the heads of regional teams and across each technology platform

·Accountable for behaviors as described in Roche's Core values

·Provide input to and rationale for department budget

·Monitor and control expenditures against department budget

·Align goals and objectives at regional sites and key business partners


TECHNICAL RESPONSIBILITY

Through leading the team and in close co-operation with Global SQM colleagues, works with quality (testing), manufacturing, PTD, supply chain and procurement functions across Roche's network to align, implement and improve supplier quality of direct materials.

·Execute established SQM processes for supplier selection, approval and ongoing management

·Investigate supplier quality issues, identify CAPAs

·Define regional audit schedule and ensure audits are performed to schedule

·Perform change control evaluations for supplier changes. Plan and execute changes for the regional and local operations

·Support global document change control, deviations and CAPAs

·Perform complaint investigations related to Suppliers

·Monitor supplier performance; Develop metrics and issue monthly metric reports for the region

·Identify, design, and implement process and system improvements as proactive measures to improve material quality

·Lead, deploy and manage the SQM compliance program for the region to include Supplier Risk assessments, for-cause-audits, and performance monitoring reviews

·Participate in supplier Risk Assessments and Supplier Analysis with Procurement

·Define and update list of strategic materials with Procurement

·Lead and participate in applicable Business and performance review meetings

·Lead continuous improvement efforts:

?Lead the process of supplier site technical (process) visits, to review entire manufacturing processes related to manufacturing of direct materials

?Lead process improvement projects with internal stakeholders and with suppliers as part of Supplier Management process to drive continuous improvement to the quality of materials and services. Is responsible for managing, negotiating and completing Quality agreements with suppliers

?Deploy Supplier Scorecards at the regional level

·Chair and/or participate in the Regional Material Review Board and Material Core Team

·Harmonize SOPs, master specifications where applicable within the regional sites

·Communicate site issues as needed to other regional managers or to SQM global level

·Participate in Global SQM leadership activities

·Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.

·Direct and participate in continuous improvement initiatives for Roche Quality Systems.

·Direct the collaboration program for Roche direct material suppliers

·Perform any other tasks as requested by Senior Management to support Quality oversight activities.

·Establish a communication plan within the regional team and across the technology platforms for Suplier Quality topics in their region and ensures alignment across the Roche network

·Provide updates and training of the group in the areas of Supplier and Management of Supplier (material and services)

·Represent Roche in customer advisory boards

·Support Supplier (material and or services) transfers to manufacturing sites and to CMOs according to plan

·Troubleshoot and direct the resolution of material and Supplier Quality issues by fostering effective inter-site, inter-departmental and cross-functional partnerships. Provide solutions to complex manufacturing, quality and negotiation problems

·Encourage vertical (regional) and horizontal (platform) synergies and efficiencies

·Participate in company External influence efforts and Best Practices efforts

·Take an active role to improve regulatiory compliance by keeping up to date with regulatory requirements


Qualifications:

· University degree in Chemistry/Biology/Chemical Engineering/ Biochemistry and demonstrated ability and experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience

·Sound knowledge of Pharma GMPs, ISO standards and international regulations

·Ability to interpret and relate Quality standards as they related to Roche and our suppliers

·Ability to make sound quality and manufacturing decisions with an E2E approach

·Candidate must be able to build relationships cross functional and with outside companies

·Must have project management experience and the ability to lead complex projects

·Must possess proven negotiation skills and the ability to influence Roche' suppliers and internal groups

·Must have knowledge of Pharma manufacturing processes, laboratory test methods, validation processes

·Knowledge of Risk and OE tools desired; i.e. statistical methods, FMEA, Six Sigma, Lean

·Candidate must be able to travel approximately 20% of the time.

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗病毒、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与政府、医疗机构以及非政府组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

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