Associate Director, Quality Assurance (Drug Substance/Drug Product)

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

• Responsible for GxP(GMP,GCP,GLP,GVP) quality and guidance tocrossfunctionalteams for late stage through commercial drug lifecycle development.

• EnsurecompliancewithallapplicableglobalGxPregulationsandguidelines

• Ensure CMO quality systems, processes, specifications, and SOPs are appropriate for clinical and commercial manufacturing, releaseanddistributionofqualityproductmeetingrelevantregulatoryrequirements,applicablestandards andguidance

• Serve as the primary QA point of contact for external manufacturing sites, contract labs, and suppliers.

• ConductQualityreview and approvalofvendormasterandexecutedbatchrecords,stabilityprotocols,validation protocols/reports and analytical protocols, methods and reports

• Conductproductreleaseof drug substance,drugproduct,packagedandlabeledproduct

• Assist inevaluationand escalation(as appropriate)of product quality issues.Ensuretimely and effective follow-up of all identified or assigned quality issues

• Drivequalityactivitiesforinternal andexternal ChangeControlsassessingproductqualityandregulatory impact

• Provide Quality review and approval for deviations, complaint investigations, and OOS/OOTs, assessing for product qualityandprogramimpact.Partnerwithinternalandexternalstakeholderstodriveissueresolution,CAPA identification and ensure timely closure

• Reviewandverifydatatoensurecompliancewithdataintegrityandregulatoryrequirements,as appropriate

• Support preparation of CMC investigational and commercial regulatory submissions by reviewing and approvingrelevantdocumentsperprogramtimelinesandassociatedHealthAuthority(HA)information requests, as required

• Assist ingeneration, tracking and trending of manufacturing quality compliance metrics and compile metrics and information for Quality Management Team reports

• FortheEU,workwiththeselectedEUDesignatedPersontoensureGoodDistributionPractices.

Quality Systems:

• Develop,reviewandapproveGxPcontrolleddocuments,suchas:Policies,StandardOperatingProcedures (SOPs),WorkInstructions, andsupportingdocumentsrelatedtoGxP activities

• Assistinphaseappropriateoversightofsystemsandoptimizesystemsastheymovefromclinicalto commercialphases

• Assistincoordinationandconductofroutineandnon-routinequalityassuranceauditsincluding: CROs/vendors,process,system,anddocumentreviewstoassurequalityassurancecompliancewith regardtoallinternalproceduresaswellasregulatoryguidelines;thiswillincludeconductingaudits

• Participateininternalauditstoidentifyareasofimprovementandcollaboratewithstakeholdersto implement effective and sustainable corrective measures

• SupportrelatedactivitiesinpreparationforHAinspectionsandsupportinteractionsduringHAinspections

• ContinuouslyimproveandmaintainQualitySystemsrelatedtoGxP activities,maintaindocumentationfor compliance with quality and regulatory standards

Requirements:

• Bachelor'sdegreeinscientificdiscipline,advanceddegreeaplus

• 6-8yearsinthepharmaceuticalindustry,withaminimumof 6yearsinQuality

• SolidunderstandingofGxPstandards,policies,andprocedures(domesticandinternational)

• Demonstrated experience and understanding of small molecule drug substance and non-sterile oral solid dosage drug product manufacturing

• GMP vendorauditingexperienceastrongplus

• Experience in commercial launch and product is preferred.

• ExperienceworkingwithCMOs

• Excellentverbalandwrittencommunicationskills

• Collaborative problem-solver, ability toanalyze complexissuestodevelop relevant and realistic plans, programs, and recommendations

• Abilitytocontinuouslyre-prioritizeandworkindependently,asamemberofacross-functionalteam,and with external vendors with minimal supervision

• Ability totraveldomestically and internationally,approx.20%ofthe time