Career Opportunities

Director of Quality ASsurance

As a Director in our Quality Assurance Department, you will be responsible for directing and overseeing the department by managing a team of QA and compliance professionals in the development, implementation, and maintenance of QA systems in support of our clinical material manufacturing facility and analytical services. You will work in a fast-paced group within the CRO environment, maintaining a satisfactory level of compliance regarding all regulatory, quality and customer-related requirements affiliated with Current Good Manufacturing Practices (cGMP).
In addition, your responsibilities will include, but are not limited to:

  • Create, revise, or approve SOPs and documents as necessary
  • Design, conduct and implement QA audits to assure adherence to company SOP, and any applicable regulatory requirements
  • Execute, maintain, and improve training program for new and existing employees including orientation, GMP training, and awareness of regulatory and quality policies/procedures and industry compliance topics
  • Ensure a system that operates effectively to manage change control, OOS’s, complaints, CAPAs and deviations
  • Assess non-compliant findings and ensuring appropriate actions are agreed and effectively followed up – implementation and management of CAPA system.
  • Participate in hosting QA inspections from existing or potential clients and regulatory agencies, e.g. FDA, EMEA, SFDA.
  • Collaborate with Corporate Compliance for Corporate Compliance Inspections
  • Lead quality input on contracts and be the primary contact for quality agreement negotiation.
  • Develop and manage quality budget with regard to personnel, administers budget, plans for future resource needs
  • Maintain adequate staffing levels; identify need for additional personnel, interview, select and train qualified candidates.
  • Conduct performance appraisals for all salaried employees in the Quality Department.

The qualified candidate will have a Bachelor’s degree in Biology, Chemistry or Life Sciences and 5 or more years QA experience with knowledge of GMP requirements and guidelines or equivalent training and/or experience. In addition, you should have:

  • Strong understanding of Quality System regulations and requirements and ability to assess and implement improvements to the existing system
  • Superb organization, communication and teamwork skills and strong interpersonal skills to be able to effectively interact within multidisciplinary groups
  • Ability to work effectively within cross-disciplinary teams and with vendors.
  • Creative problem solver and keen ability to address current and anticipated issues
  • Self-starter with high energy level and strong results orientation
  • Strong leadership skills and demonstrated success in managing a large team
  • Verbal and written fluency in Mandarin Chinese and English.

Send your C.V. with salary requirements to:

hr@wuxiapptec.com
Fax: 86-21-50461000
Mail: Human Resources
WuXi PharmaTech Co., Ltd
No. 1 Building, #288 FuTe ZhongLu
WaiGaoQiao Free Trade Zone
Shanghai, China 200131

Visit us at www.wuxiapptec.com.
Direct applicants only - no agencies please.

WuXi AppTec Co., Ltd. is a NYSE listed public company based in Shanghai, China. We offer global pharmaceutical/biopharmaceutical companies diverse outsourcing services in combinatorial, medicinal, synthetic chemistry and manufacturing of API’s and finished drug products for preclinical and clinical trials. Our clients include over 80 leading global pharmaceutical and biotech companies in the U.S., Europe and Japan.

WuXi Apptec Co., Ltd. welcomes overseas scientists to join us. We offer you a highly competitive compensation and full benefits package along with an exciting world-class research environment.

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