Head of QC

China, Jiangsu, Suzhou

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Job Summary职位概述:

  • Responsible for safe, reliable, cost-effective and efficient operation of the Quality Control organization
  • Responsible for:
    • the entire analytical laboratory operations for ClinChem, Elecsys and  materials,
    • method validation
    • customer complaint investigation
    • operation of the microbiology laboratory
    • documentation
  • Ensure ‘Right to Operate’ through compliance with all applicable GMP, SHE and other global and local regulatory requirements as well as Roche’s Quality and SHE policies and standards
  • Ensure compliance with Roche’s Group Code of Conduct
  • Ensure product market demands are met safely and delivering quality products in adequate time and quantities
  • As a member of the site leadership team, advises on key and operations related issues, initiatives and strategy for continuous improving the site operations performance

Main  Tasks & Responsibilities主要工作职责:

Technical:技术:

  • Ensure reliable quality control operations for validation purpose and commercial operations
  • Ensure reliable analytical laboratory operations for ClinChem, Elecsys and raw materials
  • Ensure reliable method validation
  • Ensure reliable complaint investigation handling
  • Ensure reliable operation of the microbiology laboratory
  • Cooperate closely within RDSZ other functions to solve product and material issues
  • Collaborate closely with other Global Operations QC functions
  • Optimize quality control output and labor efficiency while meeting required safety and quality levels
  • Ensure continuous improvement of quality controls procedures and related equipment
  • Ensure that staff are appropriately trained and qualified for the activities they perform

Safety, Health & Environment安全、健康与环境

  • Ensure that all applicable Safety, Health & Environment requirements are fulfilled to comply with corporate group policy and local legal requirements

Leadership & People Management领导与人员管理

  • Create an environment of strong team spirit and motivate and inspire teams to achieve ambitious goals in short, mid and longer term
  • Ensure timely and effective communications
  • Establish ambitious goals in line with the RDSZ site value proposition and objectives
  • Drive collaboration within site and across the network
  • Manage performance and ensure talent development for all direct functional reports
  • Manage the department population towards the set headcount target
  • Recruit highly qualified people in a timely fashion
  • Exemplify the Roche Values and Leadership Commitments

Quality and Compliance质量与合规

  • Ensure ‘Right to Operate’ through compliance with all global and local regulatory requirements applicable to RDSZ”
  • Implement and apply the RDSZ Quality Management System (QMS)

Product Supply
产品供应

  • Maximize the service level to support uninterrupted supply of high-quality products
  • Ensure that robust quality control business processes are in place

Cost Management成本管理

  • Ensure adequate budgeting for operating costs, headcount and CAPEX
  • Manage and control expenses and investments towards the set targets
  • Seek for continuous improvements in the department to optimize cost and enhance the department productivity and competitiveness

Continuous Improvement and Innovation持续改进与创新

  • Establish and maintain a culture of continuous improvement that generates tangible contributions to site operational performance
  • Support innovation by the introduction of new technologies, manufacturing and business processes and information systems as appropriate to address the changing environment, enhance existing operations and strive toward excellence in operations

General常规工作

  • Communicate the Roche Strategic Framework including the Group Business Model and the Group Management Model reinforcing the Roche values Integrity, Courage, Passion and motivate the team to live them
  • Report activities and critical issues to superiors in a timely manner
  • Support and/or implement global manufacturing, quality and business initiatives in compliance with local authority requirements
  • Support and/or implement customer complaint investigation, technical consulting and on-site supporting in cooperation with business affiliates and global organization
  • Manage and optimize relationships external authorities and communities in order to ensure a smooth cooperation

Contribute to RDSZ site activities as a member of the RDSZ Leadership Team

Qualification Required:

  • A Master’s degree in Business or Science is required
  • 15 years relevant working experience
  • Cross-functional work experience in the Diagnostics Industry (e.g. in the field of Manufacturing, Supply Chain, Quality & Regulatory).
  • Solid understanding of the QC/QM/Regulatory process including for Clinical Chemistry and Immuno Chemistry.
  • Thorough understanding of the diagnostics post launch process, with minimum 5 years hands-on QC / QM / Regulatory / business experience. Proven track record in a global Diagnostics or Pharmaceuticals business environment.
  • Knowledge of Roche internal manufacturing / supply chain / Quality and Regulatory processes, especially in Professional Diagnostics
  • Proven track record of consensus building and conflict management in challenging or difficult situations.
  • Strong leadership skills for people management and development
  • Strong business and technical acumen
  • Strong Quality/Regulatory process expertise
  • Strong communication skills
  • Strong lean supply chain process expertise
  • Strong negotiation / influencing / persuasion skills
  • Superior problem-solving skills with proven abilities to anticipate issues and recommend effective and efficient solution
  • High cultural awareness and proven ability to work and collaborate with a broad range of cultures
  • Project Management skills
  • Finance & Cost awareness
  • Neutral, non-biased analytical and strategic thinking
  • Presentation skills
  • Facilitation and conflict resolution skills
  • Proficient knowledge of Mandarin and/or English (written & spoken)