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Formulation QC Director (Wuxi, China)

Key Accountibilities:

  • Be responsible for establishment, routine operation, maintenance, improvement of Lab. system and SOPs.
  • Be responsible for qualification, validation of Lab. System and equipments.
  • Lead QC team to meet the preset goal/budget of department through streamlining/optimizing the workflow and maximizing the operation efficiency while maintaining full compliance.
  • Develop QC team including planning, recruiting, coaching, and training for staff. Provide technical guidance/direction to subordinators.
  • Be responsible for sampling, testing of materials, intermediates, finished products according to defined procedure or specification.
  • Participate in SHE, Business Compliance, cGMP, and all other compliance-related matters, where applicable.
  • Any other tasks as and when assigned by superior.
  • Requirements:

  • At least BS degree in analytical chemistry or other directly- related science.
  • Must be proficient with the requirements of the s-FDA/US-FDA/ EMEA cGMP regulations, ICH guidelines as well as drug development process.
  • More than 8 years experience in GMP in analytical or pharmaceutical industry
  • Strong project management skills & proven ability to manage complex projects. 
  • Strong interpersonal and leadership skills to participate actively to virtual teams & communicate, collaborate, negotiate & persuade across a broad variety of functions, companies and cultures.
  • Problem solving ability and adept guidance of formulation teams is also required.
  • Ability to work independently as well as in teams and represent Wuxi to clients. 
  • Creative thinking, competitive decision making&risk management 
  • She/he must develop strong collaborative relations with clients and internal customers/stakeholders across divisions to execute her/his responsibilities in assigned projects.