QC Metrology & Digitalization Team Lead (Associate Director/Director)

Responsible for routine operation of QC lab, including but not limited to:

1. 01

   Manage the routine operation of QC metrology and digitalization group to ensure the business delivery at the right quality, cost and speed.2. Manage several sub-teams like computer system management, QC DI group, equipment management and instrument management group.3. Lead the team to comply with internal

in all aspects via end-to-end quality control system oversight.4. Ensure all the activities in the team performed with compliance of cGMP, data integrity and EHS requirement.5. Oversight of the training, evaluation and management of the staff in QC lab. Coaching, developing and supporting them in reaching their full potential.6. Responsible for GMP audit from regulatory authorities and clients. Reply to audit reports and create CAPAs.Requirements:

1. 01

   Bachelor degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related discipline;

2. 02

   At least 8 years relevant working experiences in biotech or biopharma companies, including 5+ years of team management experiences;

3. 03

   A good understanding of the overall view of drug development process.4.A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.5.Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoieas.6.Comprehensive knowledge in IND/IMPD, NDA and ANDA filing7.English can be as working language.