The Product Quality Lead provides cross-functional quality leadership and supports program deliverables for assigned products and associated on-going life-cycle management activities including product transition from clinical to commercial, new product introductions and technology transfers across the network. The PQL is acting as main point of contact for providing assessment, guidance, and/or requirements relating to product quality aspects to cross-functional teams supporting the product lifecycle. The PQL is the quality representative of the development strategy of the product, ensuring global supply of IMPs and commercial products.Please not this is a hybrid role that requires on-site presence in one of our offices (Morrisville, NC or San Diego, CA).Key responsibilities:
Including, but not limited to the followingEnsure end-to-end compliance for product manufacturing and life cycle management, from clinical phase the termination of the commercialization of the product (as applicable)Provide Quality inputs in submission dossiersImplement and maintain Quality Risk Assessment and KPIsLead complex changesCoordinate product QA activities across markets (e.g. launch)Provide guidance on product quality aspects and support site transfersParticipate in audits and inspectionsDesign SOPs and contribute to operational developmentContribute to input in Quality aspect of Due Diligence processesAdvice / leads Complex quality issues and influence global solutions to ensure continuous drug supply to patients.Collaborates closely with the rest of the Quality functions to ensure product quality requirements, issues, or solutions are promptly communicated at all appropriate levelsSupport recallResponsible for coordination / issuing and approval of the APQRContribute to developing and streamlining own operationsLead & coordinate Quality aspect for integration of new acquisitionsCooperate with team members and contribute to a positive work environment
