Administration

• Responsible for whole-of-business PPM measurement & reporting, and business data management
• Create PPM information strategy, plan and design view for the PPM processes, data and systems
• Manage operational activities to support an efficient and sustainable usage of the PPM system
• Deploy leading practice reports to improve efficiency and productivity
• Develop, support and improve repeatable processes, methods, measures and leading practices across the enterprise
• Act as a data steward for data in the PPM system
• Monitor the implementation of PPM measurement systems throughout the enterprise
• Provide technical mentoring, guidance and clarification to other process experts and implementation resources
• Analyze existing measurement systems to understand and document data elements, relationships, data flow, dependencies, and related interfaces
• Monitor the enterprise PPM reporting development pipeline
• Develop new reports and enhancements to effectively communicate PPM data trends, patterns and insights
• Oversee and coordinate operational PPM tool activities
• Lead the measurement process improvement concepts/methodologies/tools/principles development

Project and Portfolio Management, Reporting & Administration

Software Engineer

• Serve as global SME for maintenance of aseptic manufacturing areas and sterile assets
• Develop and maintain global maintenance standards for aseptic equipment, cleanrooms, HVAC, and critical utilities
• Define preventive, predictive, and condition-based maintenance strategies aligned with GMP and sterility assurance requirements
• Drive asset lifecycle management, obsolescence planning, and spare parts strategies for critical aseptic systems
• Provide technical leadership for maintenance and troubleshooting of aseptic filling lines and support equipment
• Ensure maintenance activities preserve cleanroom classification and contamination control
• Ensure maintenance programs align with FDA 21 CFR Parts 210/211, EU GMP Annex 1, ISO 14644 and biotech best practices
• Support qualification and requalification activities impacted by maintenance interventions (IQ/OQ/PQ)
• Act as an engineering SME during regulatory inspections and internal audits
• Review and approve maintenance SOPs, change controls, and technical risk assessments
• Support corporate responsibility efforts for quality and regulatory compliance

Senior Global Engineering Specialist – Aseptic

• Serve as global SME for maintenance and reliability of bulk biotech manufacturing areas
• Develop and maintain global maintenance standards for bulk process equipment, utilities, and support systems
• Define preventive, predictive, and condition-based maintenance strategies aligned with GMP and product quality requirements
• Lead asset lifecycle management, obsolescence planning, and spare parts strategies for critical bulk manufacturing equipment
• Ensure maintenance practices minimize risk to product quality and cross-contamination
• Provide technical leadership for maintenance, troubleshooting, and performance optimization of bioreactors, chromatography systems, and filtration systems
• Ensure maintenance programs comply with FDA regulations and support qualification activities impacted by maintenance work
• Drive root cause analysis and implementation of sustainable CAPAs
• Identify and champion continuous improvement initiatives for equipment uptime and reliability
• Collaborate with global teams in Quality, MS&T, Automation, Process Engineering, and Operations and mentor site maintenance teams

Senior Global Engineering Specialist – Bulk

• Serve as global SME for maintenance and reliability of fractionation biotech manufacturing operations.
• Develop and maintain global maintenance standards for fractionation process equipment, utilities, and supporting infrastructure.
• Define preventive, predictive, and condition-based maintenance strategies aligned with GMP, viral safety, and product quality requirements.
• Lead asset lifecycle management, obsolescence planning, and spare parts strategies for critical fractionation equipment.
• Provide technical leadership for maintenance, troubleshooting, and optimization of:
• Fractionation tanks and large-volume vessels, Precipitation systems (e.g., ethanol fractionation), Centrifuges, separators, and decanters.
• Ensure maintenance practices support viral safety, yield, and process consistency.
• Provide maintenance expertise for utilities critical to fractionation operations, including:
• Refrigeration and freezing systems, Clean steam, WFI, PW, Process gases and inerting systems, Solvent handling and recovery systems.
• Ensure maintenance programs comply with:
• FDA 21 CFR Parts 210/211, EU GMP, Support qualification and requalification activities impacted by maintenance work (IQ/OQ/PQ).
• Act as an engineering SME during regulatory inspections and internal audits.
• Review and approve maintenance SOPs, change controls, deviations, and risk assessments.
• Support manufacturing sites in Deviation investigations and root cause analysis related to major failures, CAPA development and implementation.
• Drive root cause analysis (RCA) and implementation of sustainable CAPAs.
• Champion continuous improvement initiatives to improve:
• Equipment uptime and reliability, Mean Time Between Failures (MTBF), Maintenance efficiency while maintaining GMP compliance.
• Partner with Quality, MS&T, Automation, Process Engineering, and Operations teams globally.
• Provide mentoring and technical coaching to site maintenance and reliability teams.
• Drive knowledge sharing and best practice harmonization across the global network.
• Support deployment and optimization of CMMS/EAM systems (e.g., SAP PM, Maximo).

Senior Global Engineering Specialist – Fractionation

DevOps Engineer

• Establish and maintain the global reliability strategy that supports asset lifecycle performance, operational continuity, and alignment with CSL engineering standards
• Develop standardized reliability frameworks, tools, and metrics that strengthen work process discipline across all manufacturing sites
• Conduct global assessments to identify gaps, benchmark best practices, and ensure consistent application of reliability fundamentals
• Monitor global KPIs related to asset reliability, maintenance efficiency, and operational risk, and communicate insights to site and regional leadership
• Ensure adherence to regulatory expectations and internal quality requirements across all reliability-related activities
• Provide expert technical guidance for complex equipment challenges and high-risk investigations across the global network
• Facilitate and mentor site teams in methods such as RCM, FMEA, RCA, predictive diagnostics, and other reliability engineering principles
• Support the evaluation of new technologies, materials, and design approaches to ensure maintainability, reliability, and cost effectiveness
• Drive improvement in preventive and predictive maintenance programs, including the use of advanced diagnostic tools
• Partner with site engineering, maintenance, operations, quality, EHS, and OpEx teams to build shared understanding of reliability objectives and to strengthen network alignment
• Lead global workshops, training programs, and knowledge sharing forums that build technical capability in reliability engineering
• Promote open communication, cross-functional engagement, and collaborative problem-solving across regional and global teams
• Support global safety expectations by consistently using required PPE when on site and complying with occupational health and safety practices

Global Reliability Engineering Lead

Compliance

• Lead global EHS compliance governance processes, including controls, standards, and compliance planning.
• Oversee regulatory intelligence and ensure timely dissemination and implementation of new requirements.
• Manage the compliance aspects of the global EHS audit program, including methodology, planning, reporting, and auditor capability.
• Partner with Legal, Quality, Operations, Risk, and regional EHS teams to harmonize compliance expectations.
• Support the Global EHS Management System & Compliance Lead in delivering management reviews and compliance insights.
• Develop global compliance training materials and drive competency development across regions.
• Track compliance performance metrics and identify systemic trends and improvement priorities.
• Serve as an expert on global EHS regulations, compliance controls, and regulatory expectations.
• Lead regulatory interpretation, applicability assessment, and compliance readiness activities.
• Support site and regional teams through audits, inspections, and compliance investigations.
• Collaborate with global and regional EHS leaders to ensure aligned execution of compliance processes.
• Influence and support site leaders and functional teams in adopting compliance best practices.

Head of EHS Compliance

Director

• Lead one or more Therapeutic Areas (TA) working with the Statistics TA lead to ensure all work required in the TA is completed within the project timelines with high quality.
• Responsible for operational oversight of the site, site health and monitoring activities.
• Support QA audit and inspection planning, and implementation of CAPAs as needed.
• Identify and proactively mitigate site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs.
• Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts.
• Support sites in understanding study expectations, timelines, and required deliverables.
• Build and maintain strong, trusted relationships with investigators and site staff.

Associate Director, Site Management and Oversight Lead

Manager

• Lead the development and writing of complex bids or proposals in response to requests for proposals (RFPs) or tender invitations.
• Collaborate with leaders and cross-functional teams to develop proposal strategy.
• Manage bid timelines and deadlines to ensure timely submission.
• Explain and negotiate with government procurement teams to optimise delivery of tender bids.
• Maintain robust tender and contract management practices and drive continual improvement.
• Contribute to the Pandemic & Outbreak strategic and tactical planning and operational plan implementation.

Senior Contract Manager

QA Engineer

• Direct the strategic development of the Global PVRQA function, supporting both the global R&D business and regional affiliates.
• Harmonize processes within Global PVRQA and across other GxP areas.
• Own the long-term, risk-based audit strategy and deliver annual internal and external audit programs covering global systems, affiliates, and third-party vendors.
• Lead the preparation, conduct, and response phases for PV health authority inspections and third-party audits.
• Monitor PV system health through oversight of deviation management, CAPA, change management, and performance reporting (KPIs).
• Provide GVP consultancy and cross-GxP expertise to ensure coordination across functional areas, including Commercial and Clinical Development.
• Oversight of PV IT systems, procedural quality assurance (SOPs), and third-party/vendor management.
• Direct budget development and resource allocation by strategically assessing workload and coordinating consultant activities.
• Monitor global regulatory trends and methodologies to implement improvement initiatives in response to the evolving landscape.

Head, PV and Regulatory QA

Artificial Intelligence

• Support development and deployment of AI models, automation scripts, and intelligent agents.
• Partner with R&D teams and digital leads to identify and prototype use cases aligned to business needs.
• Contribute to MLOps processes, model documentation, and system validation workflows.
• Help drive platform integration, compliance tracking, and continuous improvement initiatives.
• Collaborate on internal capability building (e.g., hackathons, training) and end-user support.
• Track success metrics such as usage, performance, and value delivered.

Associate Director, AI & Advanced Analytics

Business Operations

• Oversee CRO execution of investigator site budgets, contracts, site payments, and ICF deliverables
• Ensure accuracy, quality, and alignment with internal templates, processes, and parameters
• Manage escalations exceeding CRO negotiation authority
• Collect, validate, and reconcile transparency‑related data
• Maintain audit‑ready records for budgets, contracts, insurance, and ICF decisions.

Senior Manager, Clinical Trial Business Operations

Procurement

• Responsible for managing the full contracting lifecycle for strategic outsourced R&D services and projects.
• Draft, review, and negotiate scopes of work, budgets, and contracts with external service providers.
• Manage vendor identification, RFI/RFP processes, proposal reviews, and contract negotiations.
• Track contractual obligations, ensure compliance, and resolve performance issues.
• Review vendor proposals and monitor ongoing spending versus budgets.
• Identify opportunities to improve contracting efficiency and contribute to tracking outsourcing metrics.

Senior Manager, R&D Outsourcing

• Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.
• Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
• Influence and contribute to clinical development plans,
• collaborate with cross-functional team for governance reviews.
• Provide statistical thought partnership for innovative study design and clinical development plans.
• Provide for project-wide planning of analyses; quality and timely delivery of interim and final results.
• Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA).
• Manage outsourcing operations or work with internal statistical programmers within the responsible program.

Associate Director, Biostatistics

Clinical Research

• Provides strategic and tactical scientific leadership and guidance for clinical development activities for 8-10 clinical scientists
• Ensures consistency of program strategy and provides appropriate oversight and scientific support of clinical scientist activities for Phase 1-4 clinical studies
• Collaborates with other Clinical Scientist Leads, Global Clinical Leads (GCL)s, Clinical Program Strategy (PST) representatives, and Global Product Leads (GPLs) to ensure adequate resourcing across the portfolio
• Ensures that resourcing is adequate to cover all roles and responsibilities of the clinical scientists in the TA
• Drives quality scientific and operational clinical development execution
• Participates in the hiring, on-boarding, training and mentoring of Clinical Scientists
• Accountable for providing guidance, training and mentorship to the scientist group
• Ensures group budget is adequately planned for, communicated and tracked in accordance with CSL processes and policies
• Provides high quality clinical & scientific content into the core clinical development documentation.

Director, Global Clinical Scientist Lead

• Lead and develop a team of Regional Account Managers by providing clear direction and support aligned to achieving marketing and sales objectives consistent with CSL Seqirus corporate values
• Achieve sales and marketing financial objectives for the private and public health business as set forth by the organization
• Coach RAM team on strategies and tactics to deliver financial results through customer engagement appointments both live and virtually
• The RAM Director requires strong product knowledge, business acumen, customer and market insights, and the ability to coach the execution of business/account plans through effective collaborative leadership
• Guide the RAM team in building strong business plans for key accounts to deliver financial goals
• Utilize internal and external data and analytical resources to understand customer and market trends
• Provide knowledge and market insights to internal stakeholder partners on key customer segments across private and public books of business-IDN’s, Medical Groups, FQHC’s, State Awardees & Departments of Health, LTC, and other healthcare sites of care.
• The RAM director should lead from the front in navigating the customer landscape to ensure we deliver value to all stakeholders clinically, financially, and operationally for an optimal customer experience
• In partnership with their RAM Team and our internal contracting team, execute all contracting requirements with large, organized customers to secure commitments for CSL Seqirus products
• Maintain exceptional customer knowledge and develop strong segment expertise to anticipate future customer needs
• Partner closely with brand and customer marketing to share insights and evolve strategy and tactics for key public and private customer segments.
• Work in close collaboration with additional sales teams in national accounts, field & inside sales, and aggregator customer groups to pull through key IDN contracts, coordinate fulfilment agreements, and maximize buying group programs in the market
• Collaborate with additional internal business partners in HR, talent acquisition, legal, compliance, market access & pricing, and customer operations to positively impact business results
• Contribute to special projects to provide customer and market insights to assist in evolving commercial strategy
• Conduct all business in and ethical and compliant manner in accordance with CSL Seqirus compliance standards
• Model our core values of patient focus, innovation, integrity, collaboration, and superior performance