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 [link removed] 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 [link removed] 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 [link removed] 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 [link removed],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

Salary and Benefits:

We offer a competitive base salary, annual bonus, and long-term incentives. In addition, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, and retirement plans.

NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.

Originally posted on Himalayas