Associate Director, Quality Operations

Kodiak Sciences is a biopharmaceutical company committed to researching developing and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases. We are focused on bringing new science to the design and manufacture of next-generation retinal medicines to prevent and treat the leading causes of blindness globally. The Associate Director Quality Operations 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 Kodiaks 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.