职位详情

  • Site Quality Director
  • 外高桥保税区
  • 面议
  • 2024-06-19 更新
  • 业务事务部Clinical Supply Services

职位属性

  • 职位数1
  • 工作性质全职

Please send your application to Recruiter.China@catalent.com. 


SUMMARY OF ESSENTIAL FUNCTIONS: 

  • Candidate must be flexible and have well-developed organizational skills and have the ability to interact with all levels of management. 
  • Candidate must be a self-starter, results oriented individual with ability to articulate, receive, disseminate and analyze data. 
  • Candidate is responsible for assisting in managing the development, implementation and maintenance of quality assurance and in process control standards and procedures as well as quality systems to ensure the precision, accuracy and reliability of company products in accordance with quality specifications, government, company and GMP standards. 


SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: 

  • Establish, Maintain and Supervise Quality Management System across Sites 
  • Direct quality team and have overall responsibilities for quality assurance, quality control. Must have a demonstrated track record of talent management; building bench strength and setting clear objectives for performance and accountability. 
  • Implement Global quality policies and standards, CSS network procedures at sites. 
  • Responsible for the quality aspects associated with global quality systems. Responsible for compliance to global standards of cGMP. 
  • Drives process efficiencies and continuous improvements to product realization and release process. 
  • Maintains contact with key customers about quality communications. 
  • Monitor Sites Training Program for compliance with GMP’s and internal procedures. 
  • Monitor Sites Supplier Management Program, provides guidance and direction for compliance with global SQM policy. 
  • Monitor Sites Deviation/ Change Control/ Complaint, involves in critical/major issues investigation and action plan. 
  • Participates in IACP audits to sites if required. 
  • Leads or assists with regulatory and customer audits of the facility as required. 
  • Other duties as assigned by VP Quality. POSITION REQUIREMENTS: Education: BS Degree in a Science or Pharmaceutical discipline. Master’s degree is preferred. Experience: Ten years of experience working in a chemical, pharmaceutical, food or relevant industry with at least Five years’ experience in QA/RA areas with progressive responsibilities. Experience in managing people, providing leadership, and implementing developmental plans for personnel. Knowledge/Skills: 
  • Must have a demonstrable record of implementing and maintaining and total quality system; laying out a strategic plan and overseeing the tactical implementation, driving improved operations and quality metrics. 
  • Successful development and implementation of a quality strategy for a manufacturing operations environment. Successful in implementing consistent standards. 
  • Experience in facilitating regulatory inspections. 
  • Strong understanding of the functional areas of manufacturing, sourcing, materials management and quality control. 
  • Understanding of QA/QC GMPs and in interpreting and enforcing regulatory requirements. 
  • Comprehensive knowledge of regulatory organizations and requirements Supervises: Quality Assurance and Quality Control encompassing QMS 


PHYSICAL/MENTAL REQUIREMENTS 

Mathematical and reasoning ability

  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.  Ability to work effectively under extreme pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds. Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. 
  • Overall about average intelligence, creative thinker with sound business judgment. Good negotiation and reasoning skills. 
  • Excellent written and verbal communications skills. Ability to easily learn and retain technical information
  • Excellent problem-solving skills, including innovative and creative solutions. 
  • Well organized with ability to handle multiple activities simultaneously. 
  • Self-starter with the ability to work with people at all levels within Catalent and within customer organizations.