Industry leading cell and gene therapy company is hiring for an Associate Director of Quality Control. Located in the Bay Area, this opportunity is a great next step in your management career.
About the Role:
Manage the day-to-day operation of the QC Laboratories (BioAssay and Microbiology)
- Prioritize workloads and testing schedules to meet client and manufacturing requirements.
- Working with Development as required, develop and qualify new test methods.
- Hire, develop, train, and evaluate QC personnel.
- Oversee documentation and implementation of the quality system to assure compliance with customer, regulatory requirements and company standards
Manage third party testing labs.
Bachelor's degree in Life Sciences or equivalent, advanced scientific degree desirable
- Minimum of ten (10) years relevant experience in Quality Control
- Minimum of five (5) years of leadership/supervisory experience
- Previous experience interacting with FDA Investigators and other Regulatory agencies
- Previous experience with management of QC Laboratories
- Understanding of Technology Transfer and method validation
- Understanding of Part 11 compliance,
- Understanding of and experience with analytical tests and assays used for cell/gene therapy testing including but not limited to Flow Cytometry, cell counting methodologies, safety testing (sterility, endotoxin, mycoplasma)
- Understanding of lean six sigma principles
- Clear understanding of compliance regulations 21 CFR 211, 21 CFR 610, 21 CFR 1271, 21 CFR 11, EU Annex 1; FACT Standards; ISO standards as appropriate