QC Head

Outstanding local biopharma

Your new company

Your new role
1. Oversee day-to-day operations of the QC testing for plasmids, vectors, and cell products including product release, stability, facility environmental monitoring, and raw materials. 2. Hire and manage laboratory personnel including managers and analysts, oversee their performance management, and mentor their career development. 3. Oversee laboratory investigations, OOS/OOT, change control, and CAPA. 4. Collaborate with analytical development, or other site QC departments, or customers for method transfer, qualification, and validation. 5. Build effective relationship with other departments such as process development, tech transfer, manufacturing, regulatory, QA, and project management to deliver products meeting customers’ needs. 6. Collaborate with IT to implement an electronic data management system. 7. Maintain the QC function in state of compliance and interface with external auditors and health authorities to support site and external inspections as required. 8. Build critical reagent management and method performance monitoring systems. 9. Assist regulatory filings worldwide. 10. Contribute to budget and resource planning and allocation

What you'll need to succeed
1. Ph.D in relevant scientific discipline with a minimum of ten years, or B.S./M.S with fifteen years of experience in quality control in biologics or cell and gene therapy. Experience in analytical development is a plus. 2. In-depth knowledge of a wide range of analytical methods including PCR, flow cytometer, ELISA,and cell based assay is highly desirable。 3. Prior success in method transfer, validation, and troubleshooting 4. Familiar with USP, EP, JP, ChP, and ICH guidelines and regulations 5. Strong organizational, staff mentorship, and time management skills 6. Be able to handle multiple projects in a fast-paced environment 7. Familiar with electronic databases 8. Excellent written and oral commination skills in Chinese and English.

What you'll get in return

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1232599

Summary

Job Type
Permanent
Industry
Pharmaceuticals
Location
Shanghai
Specialism
Life Sciences
Ref:
1232599

Talk to a consultant

Talk to Lennie Wang, the specialist consultant managing this position, located in Shanghai
Unit 1205-1212, HKRI Centre One, HKRI Taikoo Hui, 288 Shimen Road (No.1)

Telephone: 02123229656

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