Associate Director, Quality Assurance (Drug Substance/Drug Product)
Job Description:
Associate Director,QualityAssurance (Drug Substance/Drug Product)
Associate Director, Quality Assurance to assist inthe overall management of end-to-end GxP quality activities for NAP manufacturing programs specifically focusing on Drug Substance and Drug Product.Primary responsibilities will be to ensure qualityandcompliance ofNAP’s development and commercialprogramswithrespecttoQMSmanagement,controlleddocuments, and applicable regulatory requirements (FDA/ICH/EMEA, and current industry standards and practices) are conducted inacompliant manner.The team operates in a highly collaborative, results‑oriented, and fast‑paced environment, requiring a hands‑on mindset and strong cross‑functional engagement. This isa remote positionand will report to the Senior Director,QA/QC.
KeyResponsibilities:
Manufacturing Quality
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Responsible for GxP(GMP,GCP,GLP,GVP) quality and guidance tocrossfunctionalteams for late stage through commercial drug lifecycle development.
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EnsurecompliancewithallapplicableglobalGxPregulationsandguidelines
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Ensure CMO quality systems, processes, specifications, and SOPs are appropriate for clinical and commercial manufacturing, releaseanddistributionofqualityproductmeetingrelevantregulatoryrequirements,applicablestandards andguidance
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Serve as the primary QA point of contact for external manufacturing sites, contract labs, and suppliers.
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ConductQualityreview and approvalofvendormasterandexecutedbatchrecords,stabilityprotocols,validation protocols/reports and analytical protocols, methods and reports
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Conductproductreleaseof drug substance,drugproduct,packagedandlabeledproduct
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Assist inevaluationand escalation(as appropriate)of product quality issues.Ensuretimely and effective follow-up of all identified or assigned quality issues
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Drivequalityactivitiesforinternal andexternal ChangeControlsassessingproductqualityandregulatory impact
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Provide Quality review and approval for deviations, complaint investigations, and OOS/OOTs, assessing for product qualityandprogramimpact.Partnerwithinternalandexternalstakeholderstodriveissueresolution,CAPA identification and ensure timely closure
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Reviewandverifydatatoensurecompliancewithdataintegrityandregulatoryrequirements,as appropriate
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Support preparation of CMC investigational and commercial regulatory submissions by reviewing and approvingrelevantdocumentsperprogramtimelinesandassociatedHealthAuthority(HA)information requests, as required
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Assist ingeneration, tracking and trending of manufacturing quality compliance metrics and compile metrics and information for Quality Management Team reports
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FortheEU,workwiththeselectedEUDesignatedPersontoensureGoodDistributionPractices.
Quality Systems:
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Develop,reviewandapproveGxPcontrolleddocuments,suchas:Policies,StandardOperatingProcedures (SOPs),WorkInstructions, andsupportingdocumentsrelatedtoGxP activities
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Assistinphaseappropriateoversightofsystemsandoptimizesystemsastheymovefromclinicalto commercialphases
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Assistincoordinationandconductofroutineandnon-routinequalityassuranceauditsincluding: CROs/vendors,process,system,anddocumentreviewstoassurequalityassurancecompliancewith regardtoallinternalproceduresaswellasregulatoryguidelines;thiswillincludeconductingaudits
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Participateininternalauditstoidentifyareasofimprovementandcollaboratewithstakeholdersto implement effective and sustainable corrective measures
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SupportrelatedactivitiesinpreparationforHAinspectionsandsupportinteractionsduringHAinspections
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ContinuouslyimproveandmaintainQualitySystemsrelatedtoGxP activities,maintaindocumentationfor compliance with quality and regulatory standards
Requirements:
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Bachelor'sdegreeinscientificdiscipline,advanceddegreeaplus
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6-8yearsinthepharmaceuticalindustry,withaminimumof 6yearsinQuality
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SolidunderstandingofGxPstandards,policies,andprocedures(domesticandinternational)
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Demonstrated experience and understanding o