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

•         ProvidesLanghamleadershipwithupdatesonqualitymeasuresandperformancefortheoverall warehouse and distribution operations in Whiteland, IN.

•         PreparesandpresentsaccountlevelqualityperformancetoLanghamleadershiponaquarterly basis.

•         ActsasnewandexistingaccountqualityleadonbehalfofLanghamLogisticswithresponsibility for providing new clients with in-depth analysis on quality programs and metrics available through Langham Logistics business out of the Whiteland location.

•         Manageandcoordinatequalityauditsandinspections.

 MaintainsCustomerExpectations

•         RepresentsLanghamLogisticsatcustomermeetingsandquarterlybusinessreviewstoprovide information and updates on quality performance of the operations.

•         ContinuallymonitorsCQA'sandCPP'softheoperationsandmakesrecommendationsonrevised policies and procedures in order to maintain world class quality performance.

•         Servesasthepointofcontactforclientqualityrequestsincludingreporting,investigations, training updates, inspections and CAPA's.

•        Facilitatesexceptionalresponsetoroutineandnon-routineclientrequestsfordata,fulfilment, reporting,customer service support,problem resolution/investigations,and other operational or quality initiatives.

Education and Experience 

• Bachelor's Degree in Biochemistry, Chemistry, Biology, or other STEM field preferred.
• 7-10 years’ experience in Pharmaceutical and/or Life Science Quality Operations

Physical Demands 

Physical movements including bending, stooping, and lifting up to 50 pounds as part of daily work routine.  Will be working on concrete in a warehouse environment (subject to heat and cold).

Work Environment 

Work is performed in a warehouse environment subject to temperature variances.

Disclaimer

This job description is not intended to be all-inclusive. This position may be required to perform other related duties assigned to meet the ongoing needs of the organization. Langham reserves the right to modify job responsibilities and expectations as business demands evolve.

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