Senior Director, I&T Risk Management and Compliance

The Senior Director I&T Risk and Compliance Management Services for CSL's technology function (I&T), develops and implements a comprehensive risk management, quality and compliance program, tailored to the global I&T function, that meets the requirements of the Enterprise Risk Management Committee (ERMC) and CSL Quality frameworks. You will encompass tracking risks, driving risk mitigation efforts to tolerance levels, counseling around risk mitigation strategies, managing a team of professionals responsible for GxP activities, testing excellence, evaluation and ongoing management of third-party risks, and disaster recovery planning and coordination.

The Role

Risk Management Leadership and Counseling

• Develop a I&T compliance and risk management strategy that enables and help manage risk across I&T
• With the ERMC, develop a risk management framework and processes and hierarchical governance program specific to the global I&T function. Define risk assessment methodologies, risk appetite, and tolerance levels.
• Lead risk assessments to identify potential vulnerabilities and threats within the technology function. Develop and implement strategies and action plans to mitigate risks to predefined tolerance levels.
• Maintain risk register for I&T and create process to ensure accuracy of risk reporting and trend evaluation and guide on-time completion of required mitigation actions
• Create or support I&T risk programs globally including through driving CAPA and Audit finding closure and risk modeling capabilities Partner across I&T and Quality to provide a service which supports and oversees the management of I&T risk at CSL.
• Provide regular reporting metrics on the status of I&T risks globally providing input to reporting for the Enterprise Risk Committee, I&T and other senior leadership, and the Board.
• Provide guidance to technology teams on risk management, quality and compliance best practices.
• Foster a culture of risk awareness and compliance within the technology department.
• Understand and interact (maintain relationships) with related disciplines to ensure the application of policies and standards.
• Participate in incident response team including helping the team to track risk incidents and events, identify trends, and working with partners on strategies to reduce risk.

Audit Coordination and Tracking

• Coordinate all audit activity that impacts I&T ensuring efficient execution of audits or related activity, building relationships with the auditors, and meeting auditor expectations and timelines.
• Review (and coordinate review by important partners) audit/CAPA response for clarity and agreement to I&T and Quality strategy and standards.
• Track all audit issues and remediation and lead timely completion of audit actions.
• Ensure I&T maintains inspection readiness and related documentation.
• Provide audit management reporting metrics.

Quality Management Support

• Oversight and accountability for team of professionals who are responsible for ensure I&T systems and processes are compliant with Good Practice (GxP) standards where applicable, and related policies and procedures, managing timely closure of CAPA or deviations created by I&T Quality processes.
• Ensure I&T Quality management review (QMR) and related reporting for CSL Quality reporting processes are implemented with appropriate quality and generates action where needed to maintain compliance and manage risk.
• Steward and maintain I&T policies, procedures, and guidelines. Be a steward of these policies, ensuring adherence and understanding across the IT organization.

Test COE Leadership

• Manage the Testing Center of Excellence (COE) to establish standardized testing processes, methodologies, and best practices.
• Ensure rigorous testing is conducted for all IT solutions, including software, systems, and applications. Promote testing automation solutions to underpin compliance.

Disaster Recovery

• Establish the disaster recovery strategy, objectives, and standards. Implement the disaster recovery testing and training.
• Conduct risk assessments and business impact analyses to identify the potential threats and vulnerabilities to the IT infrastructure and operations.
• Consult on design and implement the disaster recovery approaches.
• Provide regular reporting and updates on the disaster recovery status, issues, and improvements to the senior management and partners.

Third Party Risk Management

• Develop a third-party risk management framework to conduct risk assessments and due diligence on existing and potential third parties to identify and mitigate cyber, and compliance risks.
• Monitor and report on the performance and risk profile of third parties and escalate issues.
• Provide counsel to I&T on third-party risk management process and modern practices.

Your Skills & Experience

• Undergraduate degree preferred. Master's degree and related certifications desirable.
• 12+ years IT, audit, quality, or technology risk management experience; specific experience in IT security risk preferred.
• 5+ years managerial experience and/or demonstrated leadership experience.
• Experience managing teams and influence within a global environment.
• Ability to create and communicate a vision with clear objectives, delineation of responsibilities and qualitative/quantitative measures.
• GxP experience is required.
• Pharma/Biotech or similarly regulated environment experience preferred.

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.