Head, Clinical Trial QA

Company: CSL
Location: King of Prussia
Posted on: March 20, 2026

Job Description:

The Opportunity: The Head of Clinical Trial Quality Assurance role maintain and enhance the Global Clinical Trial Quality System supporting Early to Late-stage clinical development projects within R&D, utilizing and improving the existing R&D Quality Management System in alignment with CSL overarching Quality Management System administered and managed by Global Quality. This position strategically oversees aspects of the R&D Quality Management in relation to key quality elements such as Document Management, Knowledge Management, Significant Issue / Serious Breach Management, Deviation and CAPA Management, Risk Management, Continuous Improvement, Inspection Management, Change Management and R&D Quality Governance associated with R&D clinical development. The role manages a Global Clinical quality department supporting early and late-stage clinical trials for all CSL business units across all R&D anchor sites. Develop and maintain an approach for inspection management related to clinical trials and the R&D QMS, focused on preparing CSLB for Sponsor Monitor inspections that will focus on R&D development programs. The Head of Clinical Trial Quality Assurance is a key leadership position for providing strategic direction and managerial oversight as the global footprint of CSLB expands. This is especially relevant as CSLB enters new emerging growth markets where integration and alignment with the global R&D Quality Management System is business critical. The Role: Direct, manage, and strategically improve clinical quality assurance (CQA) function globally. Ensuring best use of capabilities, expertise, and harmonized processes/procedures within Global CQA to enable consistent implementation of standards, integrity of processes, structures and systems on a global scale, including emerging markets Provide high quality GCP and cross functional consultancyexpertiseto guidethe R&D organization and leadership inmaintainingrequired compliance ProvideGCPandprocessrelatedguidanceandsupport Workswithteams/seniormanagementtoinvestigateandresolvenon-compliance, deviationsandprocessrelatedissuesprovidingrecommendationsfor solutions and CAPAs as needed Ensurecontinuousassessmentofkeyquality/performanceindicatorsacrossentire pre-clinical and clinical system Ensuretheprovisionofaccurateandtimelyreportsonpre-clinical/clinical development metrics, findings, and trends stemming from audits, inspections and deviations and proposes and/or implements improvement initiatives, as needed Leadappropriategovernancemeetingsandensureadequateattendance ofCQAstaff to relevant meetings globally where CQA input is required, e.g. compliance monitoring/ signals, and other governance bodies Ensureanalysisandreportingofauditobservations,gapsandsystematicissuesto relevant CSL managementfunctionsto improve processes within Pre-Clinical/Clinical Developmentaswellasaffiliates,3rdpartyvendorsandinterfacingfunctions. EvaluateadequacyandcompletenessofCAPAsoriginatingfrom audits,deviationsand/or inspections.Includingcommunication and presentation of summaries of audit findings, trends, KPIs with recommendations to drive significant continuous improvement activities Ensuretimelyreporting of seriousGxPbreaches to Regulatory Authorities, asrequired. DevelopandoverseeaGxPappropriatesignificantqualityissuesmanagementprocedure Provide leadership and guidance in the preparation, conduct and response preparation relating to health authority inspections and 3rd party audits Direct/lead preparation activities for inspections and 3rd party audits; ensure preparation of inspection strategy plans and their timely implementation, lead/ direct mock inspections/ mock inspection activities Ensure adequate communication of results and inspection preparedness to appropriate customer groups/ upper/ executive management Act as primary Inspection Coordinator during inspections, including direct interaction with inspectors in preparation, during conduct and follow-up of inspection Support CSL affiliates with external CQA audits and inspections Globally direct and actively conduct for-cause activities and other complex compliance related investigations, as needed Support of GMP/ PV health authority inspections, as required CollaboratewithotherGxPareaheadstoensureconsistencyinapproachandtoensurethere are no gaps or duplications of effort ResponsibleformaintenanceandfurtherdevelopmentofGlobalCQAsystems and processes to ensure coordination and alignment with other CSL/Global Quality and compliance functions Directandoverseeappropriateglobalworkforce planning to ensure appropriate allocation and utilization of Global CQA and QMSresources Developandevolvepartnershipandcollaborationwithpartneringfunctions Contribute ideas to the larger strategic vision of Global R&D Quality/ Global Quality and interactwiththerespectiveLeadershipTeamtoensurecontinuousalignmenton strategyandvision Skills & Experience: Undergraduate degree (BA/BS) in Scientific discipline/Life Sciences or similar. Advanced degree preferred 10 years’ pharmaceutical company experience in Quality Assurance, Quality Management Systems and/or in a Clinical Development related role Previousexperiencewith inspectionmanagementpreferred AdditionalexperienceinPharmacovigilance/GMP/Pre-Clinicalrelated roles is desirable Strong leadership role with experience in pre-clinical/clinicalregulationsandknowledgeofinternationalandnationallaws,regulationsandguidelinesrelatedtotheconduct of Research & Development Highethicalstandardsaswellasacknowledgedpersonal credibility,theabilitytogaintrustattheseniorexecutivelevel Visibleandcredibleadvocateforcomplianceandqualityconceptswith excellent communication skills across all levels of the business Analyticalandlogical,candesignandimplementinnovative,significantand complex business improvements Ability to think strategically and to quickly analyze complex circumstancesandproblems,andtodriveappropriatedecisions,actionsand resolutions Experienceofworkinginglobalcrossfunctionalteams,demonstratedabilityinmentoring/coaching/directingstafftobequalityadvocates, influencers, leaders Demonstratedabilitytoprovidevisionandleadershipwithinteams, internally cross-company and externally with stakeholders ExperienceinQualitySystemse.g.Deviation,CAPAandChange management processes Soundcustomerfocus,strongorganization,communication(writtenandoral), influencing and negotiation skills ProficientinEnglishandstandardMSOfficeapplications About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ . Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL . You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .

Keywords: CSL, Wayne , Head, Clinical Trial QA, Science, Research & Development , King of Prussia, New Jersey