Ethics & Compliance Officer EU (De, Ben, Nordics, Cluster Affiliates, Disti
Markets) (m/f/d)

Job Description

Purpose

The Ethics & Compliance Officer Europe (Germany, Benelux, Nordics + clustered affiliates and distributor markets managed by CSL Business Units in Germany, Benelux, Nordics – collectively Europe Sub-Region) implements 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"). You are also responsible for building programs, strategies and operations as established by the Regional Ethics and Compliance (E&C) Officer Europe. You will establish short term to medium term strategies to ensure that the Europe Sub-Region is risk aware, compliant and change ready across all operations 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.

You in this role are a necessary advisor in Ethics & Compliance and will partner with and support the team members in ongoing compliance risk identification, management, controls and mitigations. You will have detailed and up to date ethics & compliance knowledge in order to implement and maintain routines and ongoing schedule 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.

The Ethics & Compliance Officer will report to the Regional Ethics and Compliance Officer Europe, ensure that the Europe CSL Business Units' E&C Program direction is both consistent with and supportive of CSL Global Ethics & Compliance Program standards, actively help develop 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.

Responsibilities

• The Ethics & Compliance Officer implements strategic goals, planning efforts (budgets, operational plans), 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 E&C leadership. You are also responsible for completing programs, strategies, priorities and operations as established by Regional Ethics and Compliance Officer Europe. You will establish short term to medium strategies to ensure that the Europe Sub-Region is risk aware, compliant and change ready across all departments including Commercial, Clinical (R&D), Operations and all other Enabling functions.

• Acts as the main ethics & compliance business partner and compliance advisor, providing counsel, specialist input and expertise to CSL Business Units in Europe Sub-Region, recognized as the subject matter expert (SME) in compliance. As compliance SME you are responsible for compliance risk assessments including directing the maintenance of obligations to controls mapping and supporting the business in developing controls to mitigate issues through the issues/risks management process. Also ensure and implement compliance risk assessment schedule for all business operations and functions in Europe Sub-Region.

• Responsible for implementation of internal and external compliance standards to business practices and processes in Europe Sub-Region. Provide ongoing compliance risk advice to all business operations regarding application of internal and external (code, regulatory, legal, other) standards to business programs and impacts from regulatory and business changes. Ensures oversight and E&C standards.

• Develops and implements plans to ensure implementation of local policy and internal obligations following global/ European region direction or changes in local regulations, business conditions or from events that may affect the CSL Departments Ethics & Compliance requirements.

• Manages the execution and delivery of compliance training programs and works with business units and tasks to implement. You will not only identify requirements and provide inputs to training materials with compliance subject matter expertise, but support development of Ethics & Compliance content for compliance training programs, communicate with Legal Operations and Services to develop training communications and materials for impacted partners, and ensure adequate visibility of compliance program plans.

• Respond to alleged violations of rules, regulations, procedures, and Standards of Conduct by evaluating the need to initiate an investigation and lead and investigation in accordance with the global investigation playbook.

• Implements 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 developing policies, trainings, communications, business advice, supporting monitoring initiatives). 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 third-party onboarding and due diligence processes as part of the broader Third-Party Risk Management process. Support 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 and support business with compliance risk management processes, distributor/ 3rd party reviews and annual compliance certifications.

• Collaborate with the EREC Monitoring & Assurance team to help develop and then periodically review compliance risk based monitoring program, including audit plans and cadence. Includes providing compliance SME input into and supporting the EREC Monitoring & Assurance team with implementing a routine-controls testing program.

• Responsible for timely, relevant, focused, and applicable reporting together with the EREC Monitoring & Assurance team to provide an active Company compliance program, including oversight and monitoring of program effectiveness.

• Monitor regulatory activity and legislation as well as enforcement, environment, trade and business news, competitor activity and industry trends and related information/materials to proactively anticipate, or swiftly react to changes in business conditions or events that may impact the CSL Business Units' Ethics & Compliance requirements in conjunction with the Regional Ethics and Compliance Officer Europe.

• Proactively engages and partners with E&C, EREC, Legal and Business colleagues.

Qualifications

• Bachelor's degree in Business, Risk Management or Law; advanced degree

• 10+ years of progressive experience in compliance risk management.

• Compliance experience, in a multinational company; pharmaceutical, life sciences or manufacturing background preferred.

• Knowledge of pharmaceutical/ healthcare law, regulations, and codes of conduct

• Practical experience of implementing compliance projects

• Fluency in English (both in oral and written communication), knowledge of German and other languages is a plus.

• Excellent written and spoken communication skills, including strong presentation skills

• Stakeholder management and interpersonal skills

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

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.

We want CSL to reflect the world around us

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

Do work that matters at CSL Behring!