The Senior Manager, Research Laboratory Compliance Specialist is responsible for ensuring Research laboratory compliance through the consistent application of CSL standards, regulatory requirements, and industry best practices across CSL Melbourne Research laboratories including the Vivarium.
This role serves as the central point of accountability for laboratory compliance, providing centralised leadership, governance oversight and operational support to ensure compliance activities and effectively managed and maintained.This role partners closely with EHS, Facilities, QA, Operations, laboratory scientific teams and management to coordinate compliance programs, manage or support regulatory inspections and audits, oversee laboratory training and documentation compliance, and ensure effective management of permits, deviations, CAPAs, change controls and, risk registers.
This role requires expertise and deep understanding of regulatory laboratory guidelines and excellent communication and influencing skills to effectively collaborate with internal stakeholders in cross functional teams.Main Responsibilities & AccountabilitiesLeadership and StrategyProvide strategic leadership and oversight for Research laboratory compliance across CSL Melbourne laboratories including the Vivarium, ensuring alignment with CSL standards, regulatory requirements and industry best practicesDevelop and implement a sustainable laboratory compliance framework that supports operational excellence, audit readiness and risk reduction across ResearchEstablish compliance priorities,



governance processes and performance measures that enable proactive management of regulatory obligations and compliance risksProvide expert leadership and guidance on laboratory compliance for Research activities and laboratory operations including permitsOperational Excellence for Research LaboratoriesLead compliance oversight for Research laboratories, ensuring adherence to applicable regulatory, safety, quality and ethical requirementsLead audit and inspection readiness activities including with QA and EHS and coordinate regulatory audits and inspections where applicableEnsure audit findings, compliance actions and regulatory commitments are tracked, monitored and closed in a timely mannerManage and monitor deviations, CAPAs, change controls, risk assessments and laboratory risk registers to ensure effective compliance oversightGovern laboratory training curricula, documentation compliance and record management requirementsDrive proactive identification, assessment and mitigation of compliance and operational risks to strengthen regulatory compliance and audit readinessCollaboration and NetworkingServe as the primary point of contact for laboratory compliance, fostering solid partnerships with internal CSL teams such as QA, EHS, Facilities,



Operations and Research scientists and leadersCollaborate with internal and external stakeholders to coordinate compliance activities and regulatory interactions including for inspectionsBuild cross-relationships to ensure an integrated approach to laboratory compliance, risk management and governanceProvide compliance guidance and support to global Research teams where applicableInnovation and TechnologyStrengthen compliance capability and awareness across Research laboratories through training, guidance and continuous improvement initiativesIdentify opportunities to streamline compliance activities through standardisation and process optimisationQualifications, Skills & ExperiencePostgraduate degree (preferably MSc or PhD) and / or extensive experience in laboratory complianceMinimum of 5 years relevant industry experience and / or equivalent experience in a relevant academic environmentExperience working in cross-functional, multicultural and international teamsExperience with requirements from government regulatory agencies with deep understanding of industry best practicesExpertise in regulatory laboratory guidelinesStrong leadership and management skills.
Excellent analytical skills, ability to address complex problems through investigation and analysisOutstanding written and verbal communication skills, with the ability to present complex scientific concepts to diverse audiencesStrong networking skills and proven experience collaborating with external partnersClosing date for applications Friday 21st August ****Location: Melbourne CBD
#J-*****-Ljbffr

📌 Senior Manager, Research Laboratory Compliance Specialist (Melbourne)
🏢 CSL
📍 Melbourne