Account Manager

• Identifies external partnering needs for Recombinant IPT, supports Network Strategy make vs buy decisions, associated due diligence activities and vendor selection
• Supports drafting of agreements with external partners e.g. technical service agreements (TSA) product agreements, statements of work (SOW) and direct supply & commercialisation agreements (DCSA)
• Responsible for process and analytical technology transfer oversight between sending and receiving units through to registration
• Provides technical SMEs, including person-in-plant (PIP), for process/analytical development, manufacturing and QC testing at CDMOs through technology transfer into and during routine commercial operations
• Maintains business relationships through development and tech transfer stages transitioning responsibility to CMO Operations post PPQ/registration.
• Ensures that key parameters for process monitoring are identified and charts (e.g. time series, control charts) are set up and maintained
• Ensures key process and asset attributes relevant to reducing variability are tracked, increasing performance of the process and visualizing in reporting
• Evaluates long-term trends, maintains log of loss drivers (e.g. performance, availability and quality losses), identifies improvement levers, and identifies, prioritizes and plans robustness and continuous improvement initiatives
• Maintains capability in CMC Science that interprets developments in CMC guidance, applies relevant standards to CSL projects and diligence activities, ensuring CSL manufacturing processes meet Health Authority expectations.

Director, External Partnerships – Technology Transfer

Director

• Provides strategic leadership for clinical site operations
• Ensures effective conduct and supervision of site management activities and oversight for clinical programs
• Acts as the strategic link between therapeutic areas and investigator sites
• Leads both permanent and functional service-provider site management teams
• Cultivates strong strategic partnerships with service providers and CROs
• Develops strong and lasting relationships within Medical Affairs at the regional level and with HCPs
• Responsible for operational oversight of the site, site health and monitoring activities
• Supports QA audit and inspection planning, and implementation of CAPAs as needed
• Identifies and proactively mitigates site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs
• Provides study support on escalated site issues related to study delivery by coordinating communications and resolution efforts
• Supports sites in understanding study expectations, timelines, and required deliverables
• Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs
• Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators/CROs
• Builds and maintains strong, trusted relationships with investigators and site staff
• Serves as the sponsor primary point of contact for assigned studies
• Understands site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaboration
• Collects feedback from sites and advocates for process simplification and burden reduction internally
• Identifies opportunities to improve study materials, and operational processes

Director, Regional Head – Site Management & Oversight, Europe

Compliance

• Own and govern the Global EHS Management System, ensuring alignment with ISO 14001, ISO 45001, and internal policies.
• Develop and maintain global EHS policies, standards, procedures, and governance frameworks.
• Lead global EHS compliance strategy, including regulatory tracking, risk assessments, compliance plans, and global controls.
• Manage the global EHS audit program, including planning, execution, findings management, and CAPA oversight.
• Conduct management reviews and present EHS compliance performance, trends, and risks to senior leadership.
• Oversee regulatory intelligence processes and ensure timely communication and implementation of new requirements.
• Partner with EHS regions, Legal, Quality, Operations, and other functions to ensure global alignment and execution.
• Develop global training content and competency frameworks to ensure capability across regions.
• Maintain a centralized, auditable repository for EHS standards and compliance evidence to ensure global consistency and regulatory readiness.
• Lead continuous improvement initiatives and management system maturity advancement.
• Ensure all locations maintain a strong compliance posture with global, regional, and local EHS regulations.
• Monitor global risk trends and oversee enterprise-level corrective action programs.
• Provide guidance on regulatory interpretations and compliance strategy.
• Lead compliance investigations and root-cause analysis for systemic issues.
• Act as a strategic advisor to the Global Head of EHS on system performance, risks, and priorities.
• Lead cross-functional governance bodies related to management systems and compliance.
• Influence senior leaders and site teams to adopt consistent EHS expectations and continuous improvement.
• Provide functional leadership and direction to regional EHS management system and compliance resources, with or without direct reporting lines.

Global Head EHS Systems – Compliance

Affiliate Manager

• Develop, maintain, and integrate EHS strategic plans to drive continuous improvement in program performance.
• Interface across all areas of the business to ensure EHS decisions are aligned with internal and external stakeholders.
• Develop policies, standards, and tools for EHS compliance and risk management aligned with Centers of Excellence (CoEs).
• Ensure legal and regulatory compliance across all CSL R&D, commercial and affiliate operations.
• Identify and mitigate high-hazard and potential injury risks through proactive risk management strategies.
• Promote a safe and healthy workplace culture across all sites and functions.
• Collaborate with global and regional EHS teams to ensure consistency and best practices in compliance and risk mitigation.
• Monitor EHS performance metrics and implement corrective actions to address gaps and improve outcomes.
• Oversee medical support, pandemic preparedness, and emergency response for international business travelers.
• Oversee Biosafety Level (BSL) protocols, Chemical Hygiene Plans, and high-potency compound handling.
• Advise on safe design for new lab expansions, equipment installations, and hazardous waste infrastructure.
• Ensure R&D activities adhere to Laboratory Standards and institutional biosafety committee (IBC) guidelines.
• Lead global initiatives for ergonomics (office and field); support global initiatives for mental health and employee wellness.
• Manage driver safety training and risk management for the commercial vehicle fleet.
• Support audits, inspections, and regulatory reporting requirements.
• Champion innovation and continuous improvement in EHS practices and technologies.

Global Head of EHS, R&D

• Develop and implement a global OH & Wellness strategy aligned with EHS vision
• Lead U.S. workers’ compensation programs, ensuring compliant handling, medical quality, and efficient claim resolution
• Establish global standards, clinical protocols, and IH governance systems
• Lead global case management including early communication, functional capacity evaluations, and accommodation assessments
• Govern Australian self-insurance injury management systems and compliance audits
• Oversee international Early Intervention programs focusing on rapid triage and injury minimization
• Provide biosafety oversight in R&D settings
• Lead OH/IH global teams and manage external vendor performance
• Own global OH/IH data systems, KPIs, and reporting

Director, Global Health and Wellness

• Establish and maintain the global governance framework for OT partners, including strategic platform providers, strategic suppliers and shared service delivery models.
• Define roles, responsibilities, and interfaces between Tier 1 partners, shared services, and internal teams to avoid overlap and gaps.
• Ensure partner governance practices (reviews, escalations, approvals) are consistently applied across all regions and sites.
• Drive adherence in collaboration with DQ and CSV to GxP, safety, and regulatory expectations in all partner-delivered services and projects.
• Design and oversee the shared services structure for OT partner-delivered services (run, maintain, enhance) across PCS, MES, OSI PI, LIMS, and related platforms.
• Define the global OT service catalog, SLAs/KPIs, and RACI for internal teams, shared services, and external partners.
• Monitor service performance data and drive improvements in reliability, responsiveness, and quality of shared and partner-delivered services.
• Own and maintain global master service agreements, quality plans, service agreements, and maintenance agreements for strategic OT partners and shared services.
• Develop, standardize, and continuously improve project contracting templates for use across all OT platforms and project types.
• Oversee partner project delivery quality for OT-related operational and capital projects, ensuring adherence to global standards, templates, and governance.

Global OT Partner Enablement

Designer

• Design ownership and governance across Tier 1 capital projects ($50M+)
• Provide process technology leadership with a focus on aseptic processing
• Establish and maintain appropriate engineering design standards to ensure consistency across all CapEx projects
• Develop and manage a knowledge management program to ensure all design content is available and understood globally and at site levels
• Lead conceptual and detailed design phases for Tier 1 capital projects, ensuring compliance with cGMP, FDA, EMA, and global standards
• Validate design deliverables against project scope, budget, and schedule
• Develop initial project scope, basis of design, and feasibility assessments
• Collaborate with stakeholders to define user requirements and design criteria
• Execute design assurance reviews and health checks at key project milestones
• Identify risks and implement corrective actions to maintain design integrity
• Provide expert advice to site engineering teams on design standards and best practices
• Mentor site engineers and promote knowledge sharing across global teams
• Engage with external design partners and EPC firms to ensure quality and compliance
• Drive sustainability and modular design strategies in capital projects
• Serve as the global subject matter expert for aseptic processing technologies

Design & Technology Lead

Systems Engineer

• Serve as the primary Workday Compensation subject matter expert, providing hands‑on leadership for configuration, design recommendations, troubleshooting, and optimization of compensation and related Total Rewards functionality.
• Translate compensation operating needs into system requirements and scalable solutions, partnering with HR Systems/Technology to ensure high‑quality delivery of enhancements, fixes, and future‑state capabilities.
• Lead the technical and analytical execution for the Year‑End rewards/compensation cycle (e.g., salary review and related activities) including test support, configuration support, issue triage, reporting readiness, and post‑cycle stabilization.
• Build and maintain compensation analytics, dashboards, and decision support, ensuring leaders and stakeholders have timely, accurate insights to guide Total Rewards decisions and governance.
• Execute a roadmap of AI-enabled use cases across Total Rewards, including automation, insight generation, and process improvements that enhance accuracy, speed, and user experience.
• Apply data governance best practices to identify root causes of data/system issues, improve data quality and reliability, and strengthen confidence in compensation reporting and administration.
• Support evaluation and optimization of HR/Total Rewards technology investments, providing technical and analytical input on tool capability, value realization, and integration into the Total Rewards operating model.
• Partner with the Global Compensation Operations & Enablement Lead to support process optimization and automation by identifying opportunities, designing requirements, and enabling measurable improvements in efficiency and effectiveness.
• Provide ongoing collaboration and technical partnership with Compensation Delivery & Governance, Benefits, Executive Compensation, Performance, HR Operations, Payroll, and Finance to ensure solutions are aligned, adoptable, and operationally sustainable.
• Serve as a key liaison for compensation systems and data topics, communicating complex technical and analytical insights clearly to stakeholders to enable informed decisions and successful change adoption.

Associate Director, Compensation Systems Architect

Operations

• Oversee end-to-end case processing operations, ensuring high-quality, scientifically accurate, timely, and compliant case management across global PV activities.
• Monitor regulatory compliance within case processing workflows, ensuring alignment with local and international requirements, including data privacy and governance standards.
• Drive continuous improvements in case quality and efficiency through operational benchmarking and implementation of best practices.
• Lead case processing transformation efforts through strategic outsourcing, automation, and workforce optimization to achieve operational excellence.
• Partner with HR to implement workforce change initiatives, including role repurposing, employee retraining, and organizational redesign.
• Develop and execute cost-saving strategies, transitioning PV operations from human-led to technology-driven processes.
• Foster a culture of innovation and continuous improvement to drive long-term organizational agility and adaptability.
• Oversee intake and triage processes, including the adoption of automation solutions for initial case processing stages.
• Ensure seamless integration of new intake and triage technologies into existing workflows, improving data capture and efficiency.
• Establish performance metrics and monitoring systems to evaluate the effectiveness of intake and triage operations.
• Build and maintain strong vendor relationships to ensure high performance, quality, and compliance in outsourced PV operations.
• Develop and establish an innovative vendor oversight and management model to drive ICSR excellence.
• Define and monitor key performance indicators (KPIs) and service-level agreements (SLAs) for vendor performance.
• Collaborate with vendors to implement quality improvement initiatives and address compliance challenges.
• Oversee vendor audits and risk assessments to ensure alignment with organizational and regulatory standards.
• Collaborate with internal stakeholders, including quality, and clinical teams, to align the case management function with broader organizational goals.
• Manage and oversee budgets for Case Management, ensuring financial targets and project milestones are achieved.
• Communicate transformation goals and progress to senior leadership, ensuring alignment with the organization’s strategic vision.
• Establishment and maintenance of a high performing outsourced medical evaluation function.
• Directing the medical evaluation strategy ensuring a consistent, scientifically robust approach embedded in CSL’s signal detection framework.

Head of Pharmacovigilance Operations

Risk

• Accountable for leading the strategic development, implementation, and oversight of Environmental, Health, and Safety (EHS) and environmental risk management programs across all global operations
• Ensures proactive identification, assessment, and mitigation of EHS and environmental risks
• Drive global risk governance and foster a culture of safety and environmental compliance
• Develop and execute global EHS risk management and environmental management strategies aligned with corporate goals
• Lead enterprise-wide risk assessments and implement mitigation plans for high-impact EHS and environmental risks
• Establish and maintain global EHS and environmental governance frameworks, policies, and procedures
• Ensure compliance with international EHS and environmental regulations, standards, and best practices

Global Head EHS Risk Management – Environmental Lead

• Reporting to the Chief Corporate & External Affairs Officer
• Oversee all communications for CSL Operations globally
• Ensure CSL’s enterprise priorities are communicated effectively
• Shape and drive the communications strategy that positions Global Operations as a competitive advantage for CSL
• Lead the strategy and execution of all communications relating to Global Operations

Senior Director, CEA Operations – Global Site Communications

• Lead the global environmental compliance strategy, ensuring adherence to international regulations and standards (e.g., ISO 14001, local environmental laws).
• Develop and implement environmental risk mitigation frameworks across all capital projects and operational activities.
• Oversee global environmental audit programs, compliance monitoring systems, and corrective action processes.
• Integrate sustainability goals and environmental performance metrics into business operations and strategic planning.
• Partner with cross‑functional teams to embed environmental compliance into product development, manufacturing, supply chain, and commercial operations.
• Provide expert guidance on environmental permitting, reporting, and regulatory engagement.
• Monitor emerging environmental regulations and trends, ensuring proactive adaptation and compliance.
• Lead environmental training and awareness programs to build organizational capability and culture.
• Support incident investigations and root cause analysis related to environmental non-compliance.
• Develop governance frameworks and policies for environmental compliance and sustainability integration.

Global Environmental Director

Full-stack Engineer

• Provide subject matter expertise to ensure process, equipment, and product performance throughout the lifecycle.
• Serve as a technical reference for complex or nonroutine manufacturing and engineering topics.
• Support or lead technology transfer, scaleup/down, modernization, and lifecycle management initiatives.
• Support daily operations by troubleshooting process and equipment issues, using structured root cause methodologies and data analytics.
• Ensure timely closure of deviations, CAPAs, change controls, and regulatory commitments.
• Analyze production and analytical data to identify trends, risks, or improvement opportunities.
• Apply risk assessment tools (FMEA, PRA) in deviation assessments, validation approaches, and design decisions.
• Lead or contribute to S&I and OPEX/CAPEX projects, ensuring technical excellence, compliance, and alignment with industry standards.
• Identify and execute continuous improvement initiatives focused on yield, quality, reliability, efficiency, and cost.
• Develop and execute scientifically sound, risk-based validation strategies for equipment, systems, or processes.
• Provide technical support during internal and external inspections, ensuring clear articulation of process, engineering, or validation rationales.
• Work cross functionally with Manufacturing, Quality, Engineering, R&D, and Global Functions.

Principal Engineer, Tech Ops

• Develop, validate, transfer, and life cycle of test methods for vials, transfer devices, e.g., vial-to-vial transfer, syringes, needle-safety devices, autoinjectors, and on-body drug delivery systems.
• Conduct testing with appropriate methods, protocols specifications and equipment (includes product and/or equipment testing), including adhering to test schedules, e.g., stability pulls.
• Establish capabilities and technologies to support product development pipeline.
• Specify, design, and procure specialized test fixtures.
• Author and review rigorous technical documents for inclusion in DHFs, to support regulatory submissions, and to address regulatory inquiry.
• Specify, install, qualify, and maintain test equipment.
• Support the laboratory operation such as sample inventory, equipment qualification, calibration, and maintenance.
• Schedule workload and communicate challenges, scheduling, testing conflicts or other issues to management in timely manner.
• Comply with CSL’s quality assurance requirements and applicable regulatory requirements.
• Actively participate in team efforts to collaboratively deliver development project results.
• Use good judgement and laboratory practice to productively and safely execute testing and test method development in shared laboratory workspace.

Principal Engineer, Tech Ops – Drug Delivery Systems Testing & Verification

• Set and drive best practices within DDSP for primary packaging development.
• Collaborate with key stakeholders in CSL to evaluate new device technologies to meet pipeline needs.
• Lead primary packaging engineers and scientists to effectively handle commercial biological/drug-device combination product development.
• Guide integration of primary packaging system development with CMC, device development, and Verification and Testing workstreams to influence and enable CSL clinical asset development strategy.
• Ensure container closure system control strategy and test methods are appropriately developed and qualified to inform design decision-making and enable control of device/containers/packaging performance.
• Provide input on behalf of DDSP on aseptic filling processes and controls to CMC as well as external CMOs.
• Create and maintain standard operating procedures, work instructions, and templates for DDSP to use in the development of primary packaging.
• Work closely with Business Units, Affiliates, and Manufacturing to ensure the appropriate qualification of primary packaging and the successful tech transfer to manufacturing sites to enable commercial strategies.
• Provide in-depth technical advice and guidance beyond DDSP department.
• Work with CMC, Operations, and QC lab organizations to assess projects for design and process risks and use resources to mitigate those risks before they affect the project delivery timeline.
• Identify and develop talent to meet DDSP business requirements. Plus develop robust succession plans that provide career opportunities for individuals while supporting business resiliency.
• Provide Primary Packaging budget input for projects.
• Author and or review technical documents for regulatory submissions and responses to regulatory agency questions on combination products.
• Ensure that material science translates into flawless industrial performance by providing mathematical rigor and statistics to move beyond “trial and error” utilizing six sigma principles.