Ethics & Compliance Officer Eu (Sp, It, Fr, Cluster

hace 2 semanas

Barcelona, España Seqirus A tiempo completo

The Ethics & Compliance Officer Europe.

(Spain, Italy & France + clustered affiliates and distributor markets managed by CSL Business Units in Spain & Portugal, Italy, and France - collectively Europe Sub-Region)

The Ethics & Compliance Officer Europe is responsible for implementing strategic goals, planning efforts, managing projects, and providing measurable inputs into processes, standards and operational plans for the Ethics & Compliance function for all CSL Group entities, in Europe including CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor (“CSL Business Units”). The incumbent is also responsible for executing programs, strategies, priorities, and operations as established by the Regional Ethics and Compliance (E&C) Officer Europe. The role is responsible for establishing short term to medium term strategies to ensure that the Europe Sub-Region is risk aware, compliant and change ready across all business functions including Commercial, Clinical (R&D), Operations and all other Enabling functions across CSL Plasma, CSL Behring, CSL Seqirus and CSL Vifor businesses in Europe Sub-Region.
The incumbent in this role is a key advisor in Ethics & Compliance and will partner with and support the business stakeholders in ongoing compliance risk identification, management, controls and mitigations. The incumbent will have detailed and up to date ethics & compliance knowledge to implement and maintain routines and ongoing cadence to manage, monitor and analyse regulatory/enforcement and business changes as well as suggest ‘best practices’ in the industry to the Regional Ethics and Compliance Officer Europe, and then recommend them for action.

Responsibilities Include:
- The Ethics & Compliance Officer will report to the Regional Ethics and Compliance Officer Europe, ensure that the Europe Sub-Region CSL Business Units’ E&C Program direction is both consistent with and supportive of CSL Global Ethics & Compliance Program standards, actively contribute to developing a Company culture of compliance and support the business through client counselling, training/ communications, auditing and monitoring, Speak Up hotline report review, investigation and remediation. The Ethics & Compliance Officer is responsible for implementing strategic goals, planning efforts (budgets, operational plans etc.), managing projects and providing measurable inputs into processes, standards, and operational plans for the Ethics & Compliance function for CSL Business Units in Europe Sub-Region in collaboration and consistent with Europe Regional and Global E&C leadership. The incumbent is also responsible for executing programs, strategies, priorities, and operations as established by Regional Ethics and Compliance Officer Europe. The role is responsible for establishing short term to medium strategies to ensure that the Europe Sub-Region is risk aware, compliant and change ready across all business functions including Commercial, Clinical (R&D), Operations and all other Enabling functions.
- Develops and implements plans to ensure implementation of local policy and internal obligations in accordance with global/ European region direction or changes in local regulations, business conditions or from events that may impact the CSL Business Units Ethics & Compliance requirements.
- Responds to alleged violations of rules, regulations, policies, procedures, and Standards of Conduct by evaluating the need to initiate an investigation and leads investigation in accordance with the global investigation playbook.
- Leads implementation of strategic compliance risk management and co-chairs with the leadership of CSL Business Units in Europe Sub-Region the quarterly compliance committees by staying current on development and treatment action plans for top compliance risks and identifying potential areas of improvement to further enhance compliance program (including but not limited to developing policies, trainings, communications, business advice, supporting monitoring initiatives, etc.). The incumbent will support the business to develop/implement corrective action plans for resolution of problematic issues and provides general guidance on how to avoid or deal with similar situations in the future.
- Responsible for effective third-party onboarding and due diligence processes as part of the broader Third-Party Risk Management process. Supports the EREC Monitoring & Assurance team in providing SME input to develop the select monitoring program for third party risk assessments. Provides/ enables targeted ethics & compliance training as needed and support business with compliance risk management processes, distributor/ 3rd party reviews and annual compliance certifications as needed.
- Collaborates closely with the EREC Monitoring & Assurance team to support the development of and then periodically review compliance risk based monitoring program, including audit plans and cadence. Includes providing compliance SME input into and suppor

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