DescriptionThis team member is responsible for developing, implementing, and managing Quality operations system in the organization to ensure compliance of biological products with cGMP and regulatory requirements. This role is on-site at Kodiak's headquarters in Palo Alto, CA.
Key Responsibilities- Develop, implement, and manage quality system procedures.
- Represent QA in supporting technology transfer and process validation activities at CMO sites.
- Investigate deviations and implement CAPAs as needed.
- Review and approve analytical data and batch records.
- Review and release drug substance and drug product batch documents.
- Support internal and external audits as needed.
- Maintain and support regulatory submissions as needed.
- Identify KPIs and establish and drive continuous improvement to maximize efficiencies in the quality processes.
- Coordinate with cross functional departments for routine work and problem solving
- Support development of Pre-Filled Syringe (PFS) for intravitreal delivery of viscous drug product
- Support Bioanalytical lab in developing operational procedures, provide quality oversight for method validation and compliance efforts to meet GLP/GCLP requirements.
- Support Computer System Validation (CSV) activities for digital systems impacting GxP activities.
- Support active clinical trial supply and demand activities,
- Supports any additional projects assigned by Senior Management.
Education/Experience- At least a BS in Pharmaceutical Sciences or related field.
- 5-7 years of technical experience within regulated industry.
- Experience and knowledge of quality management system required.
- Preferred experience with biologics and pre-filled syringe.
- Experience in analytical methods, equipment/facilities validation and technology transfer experience is a plus.
- Experience in a cGMP environment is required, and experience in supplier management is a plus.
- Ability to learn quickly and make sound, scientifically driven decisions that align with regulatory requirements.
