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.
Desired Qualifications:
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
