Regional Ethics & Compliance Officer, ICO

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About CSLWith operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world’s largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!Job DescriptionThe Regional Ethics & Compliance Officer ICO is responsible for establishing, directing and implementing all strategies and operational plans to embed and implement the CSL global enterprise-wide Ethics & Compliance (E&C) framework, across Behring, Plasma and Seqirus, and across all businesses and functions (which includes ComOps, R&D, Manufacturing, Plasma and all other functions including Enabling Functions) in the ICO region to ensure compliance with (non-GxP) laws, regulatory requirements, policies, and procedures of each applicable country. The role is responsible for creating and establishing short term to medium term strategies to ensure that the ICO region is risk aware, compliant and change ready across all businesses and functions. The role (in consultation with the Chief Ethics & Compliance Officer) also influences and contributes to the update of CSL Global enterprise wide E&C framework, and Risk Management processes to ensure that regional laws and regulations are built into the overall frameworkThe incumbent in this role is a key business partner and Subject Matter Expert in Ethics and Compliance in the ICO region and will partner and advise the business in ongoing compliance risk identification, management, controls and mitigations. It drives the ongoing development of ethics and compliance risk awareness in the ICO organisation and embedding compliance in Behring, Seqirus and Plasma organisations in the region. The role will proactively and regularly identify opportunities for improvement including technology (in collaboration with IT) and recommend those to the Chief Ethics & Compliance Officer and once approved ensure implementation in accordance with agreed plans.

It will have detailed and up to date global ethics and compliance knowledge as well as design, establish and maintain routines and ongoing cadence to manage, monitor and analyse regulatory/enforcement and business changes as well as considering ‘best practices’ in the industry to proactively anticipate any impacts to CSL, and then recommend them for action .The Regional Ethics & Compliance Officer ICO is the E&C leader for CSL group businesses and functions in the ICO region and is responsible for establishing operational plans, regional policies and standards, and to ensure implementation of the global Ethics & Compliance program for CSL at the regional level. This role is responsible for establishing procedures to ensure that the compliance programs throughout the ICO region are effective and efficient in identifying, preventing, detecting, and correcting noncompliance with applicable laws and regulations.RESPONSIBILITIES AND ACCOUNTABILITIESResponsible for establishing, directing and implementing all strategies and operational plans to embed and implement the CSL global enterprise-wide Ethics & Compliance (E&C) framework, across Behring, Plasma and Seqirus, across all businesses and functions (which includes ComOps, R&D, Manufacturing, Plasma and all other functions including Enabling Functions) in the ICO region, ensuring compliance with (non-GxP) laws, regulatory requirements, policies, and procedures of each country in the region. Collaborates closely with Ethics & Compliance Leadership Team (E&CLT) and other key business partners across the organization to ensure all ICO regional ethics & compliance related programs, processes and policies align with global E&C objectives, business objectives and is integrated into business activities as needed. Implements and maintains the Global Ethics & Compliance program regionally. Responsible to ensure compliance risk advice and guidance that is provided for business operations in the ICO region (including Behring, Plasma and Seqirus and all associated business functions) comply with internal company and external (code, regulatory, legal, other but non-GxP) standards to business practices and programs. Engages/serves as the principle Ethics & Compliance contact and key business partner for the ICO region in regional compliance related discussions and ad-hoc interactions to support ongoing compliance risk identification and management. Supports the business in undertaking regional ICO Ethics & Compliance ‘deep dives’ as required and developing controls to mitigate issues through the issues/risks management process. Proactively supports the functions and businesses in assessing their compliance risk profile and advising where compliance risk controls are needed. Advises the business teams on ethics and compliance standards and requirements and actions needed to prioritize and assure timely compliance. Collaborates with Legal Services & Operations to identify requirements to develop, deliver and/or conduct ethics and compliance training for stakeholders as and when required. Has expert level knowledge of and is responsible for monitoring of, external regional environment for new/ changed legal, regulatory, enforcement standards including local/regional regulatory, enforcement, environment, trade, and business news, as well as competitor activity and industry trends. Recommends swift responses to changes / anticipated changes in business conditions or events that may impact CSL’s Ethics & Compliance and operations. Responsible for effective third-party due diligence and onboarding processes for the region as part of the broader Third-Party Risk Management technology and process. Supports the EREC Monitoring and Assurance team in providing SME input to development of the select monitoring program for third party risk assessments. Provides/ enables targeted ethics and compliance training as needed and support business with compliance risk management processes, distributor/ 3rd party reviews and annual compliance certifications as needed. Responsible for investigation and remediation of the Speak Up hotline and other reports of serious concerns relating to regional activities. Drives the investigation process involving other internal and/or external stakeholders as appropriate (Legal, HR, external forensic firms, etc).

Includes responsibility for analysis of regional results for trends or other emerging issues and proposing actions to address in conjunction with the CE&CO and the global E&C LT. Responsible for defining local or regional policies and internal obligations in accordance with changes in local regulations, business conditions and aligned with global E&C policies and programs.

Responsible for oversight and maintenance of the ICO regional repository of ethics and compliance related information for all ICO employees (new and existing) to easily access and ensure all information is periodically reviewed and kept up to date at all times.

Defines compliance risk assessment cadence and program to assess risk across key sites and functions in the region. Leads and directs regional ethics and compliance risk assessments, manages communication of resulting reports/ recommendations/ specialist advice and supports any required business remediation plans/ corrective actions. Provides specialist advice to the business to assess ethics and compliance risks, considering the CSL risk appetite, and supports local business stakeholders to assess the current compliance risk by evaluating the risk factors and key data inputs.

Supports the business to develop controls to mitigate issues through the issues/risk management process. Collaborates closely with the EREC Monitoring & Assurance team to support the development of and then periodically review a regional compliance risk based monitoring program, including audit plans and cadence.

Supports the EREC Monitoring & Assurance team to ensure that the monitoring and reporting program is in accordance with related policies and standards providing subject matter expert (SME) input for ethics and compliance. Includes providing compliance SME input into and supporting the EREC Monitoring & Assurance team with implementing a routine-controls testing program. Responsible for maintaining the regional obligations to controls mapping and adds to the global controls mapping. Works closely with the EREC Monitoring & Assurance team to review and provide specialist input for ethics and compliance reporting and meeting reporting requirements and deadlines in accordance with the Global Compliance Committee (GCC), Enterprise Risk Management Committee (ERMC), Board/ARMC and risk governance requirements. In partnership with regional business leadership, manages regional (and supports Global, as needed) ethics and compliance committees and support committees’ recommendations and action plans. Ensures escalation of any risks or issues as appropriate to the GCC. Supports the CE&CO in development and implementation of effective systems, processes and operations for early risk detection, prevention, and remediation as well as continuous ethics and compliance program assessment and improvement. Proactively a