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Associate Director, Quality Operations

Kodiak Sciences

Palo Alto, CAFull-timePosted 2mo agoStill listed 2 days ago

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At a glance

Compensation
No compensation found
Location
Palo Alto, CA
Schedule
Full-time
Work Authorization
Not specified

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Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

Kodiak Sciences is hiring an Associate Director, Quality Operations. The Associate Director, Quality Operations, is responsible for developing, implementing, and managing Quality operations systems to ensure compliance of biological products with cGMP and regulatory requirements. This role supports technology transfer and process validation activities, investigates deviations, and implements CAPAs. They will also review and approve analytical data and batch records, and support internal and external audits.

Key focus areas include Develop, implement, and manage quality system procedures, Represent QA in supporting technology transfer and process validation activities at CMO sites, and Investigate deviations and implement CAPAs as needed.

Successful candidates bring Bachelor’s In Pharmaceutical Sciences Or Related Field, 5–7 Years Technical Experience Within Regulated Industry, and Experience And Knowledge Of Quality Management System. Important skills include Develop Quality System Procedures, Implement Quality System Procedures, Manage Quality System Procedures, Technology Transfer, Process Validation, and Investigate Deviations. Preferred (not required): Biologics, Analytical Methods, Equipment Validation, and Facilities Validation.

Skills & qualifications

RequiredNice to have

Skills

Develop Quality System ProceduresImplement Quality System ProceduresManage Quality System ProceduresTechnology TransferProcess ValidationInvestigate DeviationsImplement CAPAsReview Analytical DataApprove Analytical DataReview Batch RecordsApprove Batch RecordsReview Drug Substance Batch DocumentsRelease Drug Substance Batch DocumentsReview Drug Product Batch DocumentsRelease Drug Product Batch DocumentsSupport Internal AuditsSupport External AuditsMaintain Regulatory SubmissionsSupport Regulatory SubmissionsIdentify KPIsEstablish Continuous ImprovementDrive Continuous ImprovementCoordinate With Cross Functional DepartmentsProblem SolvingSupport Pre-Filled Syringe DevelopmentDevelop Bioanalytical Lab Operational ProceduresQuality Oversight for Method ValidationComputer System ValidationSupport Clinical Trial Supply and DemandQuality Management SystemLearn QuicklyMake Sound Scientifically Driven DecisionsAlign Decisions With Regulatory RequirementsBiologicsAnalytical MethodsEquipment ValidationFacilities ValidationVendor Management

Qualifications

BS in Pharmaceutical Sciences or Related Field5-7 Years Technical Experience Within Regulated IndustryExperience in a cGMP Environment

Full job description

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 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 e stablish 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.

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