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Senior Director, GLP Quality Assurance (Shanghai, China)

Overview:

  • This position is located in Suzhou China.  Support and immplement the overall quality vision and strategy for WuXi AppTec Co., Ltd. Good Laboratory Practice (GLP) Laboratories in Suzhou and other GLP Operations, China. In addition, provide Quality Management system oversight to non-regulated operations at WuXiAppTec Co. Ltd., China. Provides strategic and operational leadership for the development and implementation of a consistent quality system in these Laboratories. Ensures compliance with local and international GLP regulations. Supports the development of a high performing team of QA associates
  • Key Accountibilities:

  • Work with the QA management to define the strategy for quality management in WuXi AppTec Co., Ltd. GLP Laboratories including process reengineering or continuous process improvement and quality training.
  • Support the development and implementation of a WuXi AppTec Co., Ltd. GLP-wide quality system and Quality Management System (QMS)
  • Participate in the expansionof GLP principles and international laboratory quality standards (e.g. ISO) to other laboratory areas in WuXi AppTec Co., Ltd. as requested.
  • Participate in communication with all levels of laboratory personnel and line management on purpose, direction, and goals of quality management.
  • Review and approve QA regulatory documents when required.
  • Conduct and report QA activites in support of BU regualtory activities, i.e., study inspections/audits, vendor audits, and facility inspections
  • Assure regulatory authority inspections are fully supported
  • Provide input to GLP QA Suzhou SOPs, and BU Operational SOPs
  • Ensure consistent inspection practices of GLP QA operations within China
  • Assume the responsiblities and role of VP GLP QA when delegated.
  • Monitor local projects so that work is on course to meet regulatory or client submission dates
  • Oversee local QA work prioritization and resource management
  • Provide local QA groups with general direction and guidance.
  • Requirements:

  • Degree in Natural Sciences or Medicine or related experience
  • At least 15 years  experience in medical or preclinical Research & Development
  • Understanding of Quality systems and global regulatory (GLP) requirements
  • li communication and negotiation skills
  • Excellent interpersonal and leadership skills
  • Excellent communication, both written and oral, in English and Mandarin
  • Preferred:
  • -- Knowledge of drug development process

    -- Working knowledge of relevant IT systems

    -- Proactive compliance philosophy

    -- Organization skills

    -- Significant prior experience in GLP QA