Sr Labeling Project Coordinator

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

Key Responsibilities :

Serveasalabelingsubjectmatterexpertandprovideguidanceacross Regulatory Affairs ,Legal,Package Engineering,Quality Assurance.

Label Template Review and Approval review and approve label design templates

Leadandsupportcomplexlabelingprojectswhereestablishedprecedentsmaynotexist,requiringindependentjudgmentandinnovativeproblem-solving.

Managecross-functionallabelingimplementationactivitiestoensureproductlabelingchangesareexecutedaccuratelyandwithinrequiredtimelines.

Coordinatetheimplementationofnewlabelingwith Materials Managementandmultiplemanufacturingorpackagingsites .Drivethecompletionofcomplexlabelingprocessesbycollaboratingwithstakeholdersandensuringcompliancewithregulatoryandbusinessrequirements.

Developandrecommendprocessimprovementsbasedonnovelapproachestoexistinglabelingoperationsandworkflows.

Author,revise,andimprovesystems,procedures,andSOPstoenhancelabelingefficiencies,compliance,andoperationaleffectiveness.

EnsurelabelingactivitiescomplywithFDAregulations,cGMPrequirements,andapplicableregulatoryguidancedocuments.

Facilitatecommunicationandalignmentamongcross-functionalteamstoresolvelabelingissuesandsupportsuccessfulimplementation.

Supportcontinuousimprovementinitiativesfocusedonlabelingaccuracy,compliance,consistency,andoperationalexcellence.

Basic Qualifications:

At least 5 yearsofrelevantexperiencewithaBS/BAdegree,ORAt least 4yearsofrelevantexperiencewithanMSdegree.

Pharmaceuticalindustryexperiencerequired.

StrongknowledgeofFDAregulations,cGMPrequirements,andregulatoryguidancedocuments.

Demonstratedexpertiseinproductlabelingoperationsandlabelingimplementationprocesses.

Strongverbalcommunication,technical writing,andinterpersonalskills.

Experiencemanagingcomplexcross-functionalprojectsandstakeholderrelationships.

Proficiency with Microsoft Office applications .Abilitytodevelopprocessimprovements,driveoperationalchanges,andworkeffectivelyinambiguousorevolvingenvironments.

Preferred Qualifications:

Labeling experience preferred

Onsite Requirement: 3x days per week

The salary range for this position is: $ - $. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits include company-sponsored medical, dental, vision, and life insurance plans*.For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is…