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Quality Manager impacts the organization by leading the quality unit of life science warehouses and distribution facilities and acting as the primary authority for all decisions affecting quality aspects of the operations including processes, policies, work instructions,and implemented practices.

The Quality Manager will interface directly with the respective quality counterparts of all clients serviced. This position drives the quality culture, establishes policies and procedures, oversees implementation of learning management toolsandacts astheliaisonforallregulatoryagencyinteractionsonbehalfofLangham LifeSciences and in compliance with the client quality standards for pharmaceutical distribution operations.

This position oversees the Quality personnel and is accountable forall quality measures of performance for the operations.

Key Outcomes Expected 

• Drivesthedevelopmentofqualityculture,strategy,policy,warehouseteamobjectivesand overall processes affecting Quality Assurance in conjunction with clients.
• InterpretsandappliesapplicableGxPregulations/policiestouniqueandoftencomplexissues.
• Managesinternalandexternal,routineandnon-routineaudits/assessmentsaswellasquality projects related to regulatory inspections and potential non-compliance observations
• InpartnershipwiththeOperationsManager,managesresources,priorities,schedulesand/or projects to assure delivery of the operational quality objectives.
• Leadsallprojects,programsorteamdevelopmentactivitiesthathaveGxPcompliance implications.
• Contributestoaqualitycultureenvironmentthatoptimizesemployeeproductivityand participation and adds value to the client.
• Develops warehouse operations team skill sets and knowledge base to ensure ongoing compliancewithevolvingregulationsandexpectationsforqualityperformancefromthe client(s).
• Directstheactivitiesofoneormoredirectreportsand/orleadsamatrixteamorbusiness processes, as required for effective management of the quality program.
• Activelyengagesinriskmanagementactivitiestoidentifyeffectiveriskmanagementstrategies including the escalation of risks and their solutions.
• Actasacoach,mentorortrainertodevelopapassionforqualityinothers.
• Proactivelyidentifies,communicates,andmonitorsbusiness/regulatorychangesthatcould impact the quality position of the warehouse operations.
• Providessuitablerecommendations/mutualsolutionsthatshowmeasurablequality improvement and added value to internal/external customers.
• Engageswiththebusinessinstrategic/operationaldecisionsonbehalfoftheclient(s).

QualityPerformanceExpectations