My client is a global name in the biotechnology sector and is going through a period of expansion. It now seeks an experienced QC Manager to manage global CMOs based in Europe.
Responsibilities
- Act as the direct liaison with the QC team within CMOs for all QC related activities
- Assume responsibility for leading, coordinating and managing all activities associated with QC testing and release during the routine phase.
- Ensure all QC test methods are being transferred and qualified prior to being used to support clinical and commercial manufacturing
- Responsible for reviewing QC test reports, test protocols and other associated documents generated from CMOs
- Perform method monitoring/trending for identified parameters to ensure methods reliability.
- Work with subject matter experts on the respective methods to provide technical advice to CMOs
- Ensure necessary equipment qualification and assay validations are complete
- Prepare responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA)
Requirements
- Advanced Degree in Biology, Biotechnology, Life Science, or equivalent with at least 8-12 years' experience in a GMP environment
- Strong understanding of current requirements of Biologics
- Experience with biochemical analysis - such as immunoassay, cell-based assay
- Experience in Cell Therapy facilities will be a big plus
- Prior experience in managing CMOs
- Excellent communication and negotiation skills
- Ability to lead a huge team
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).
