The Ethics & Compliance Officer UK & Ireland 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 UK & Ireland including CSL Behring, 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 UK & Ireland is risk aware, compliant and change ready across all business functions including Commercial, Clinical (R&D), Operations and all other Enabling functions across CSL Behring, CSL Seqirus and CSL Vifor businesses in UK & Ireland.
Responsibilities include: -
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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.
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The Ethics & Compliance Officer will report to the Regional Ethics and Compliance Officer Europe, ensure that the UK & Ireland 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.
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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 UK & Ireland 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 UK & Ireland is risk aware, compliant and change ready across all business functions including Commercial, Clinical (R&D), Operations and all other Enabling functions.
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Acts as the key ethics & compliance business partner and compliance advisor, providing counsel, specialist input and expertise to CSL Business Units in UK & Ireland, recognized as the subject matter expert (SME) in compliance. As compliance SME the incumbent is 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 ensures and implements compliance risk assessment cadence for all business operations and functions in UK & Ireland
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Responsible for implementation of internal and external compliance standards to business practices, programs, and processes in UK & Ireland. Provides ongoing compliance risk advice and guidance to all business operations regarding application of internal and external (code, regulatory, legal, other) standards to business practices and programs and impacts from regulatory and business changes. Ensures consistent oversight and E&C standards.
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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.
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Manages the execution and delivery of compliance training programs and works with business units and functions to implement. The incumbent 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, liaise with Legal Operations and Services to develop training communications and materials for impacted stakeholders, and ensure adequate visibility of compliance program initiatives.
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Responds to alleged violations of rules, regulations, policies, procedures, and Standards of Conduct by evaluating the need to initiate an investigation and lead and investigation in accordance with the global investigation playbook.
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Leads implementation of strategic compliance risk management and co-chairs with the leadership of CSL Business Units in UK & Ireland 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.
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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.
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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 supporting the EREC Monitoring & Assurance team with implementing a routine-controls testing program.
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Responsible for timely, relevant, focused, and actionable reporting in conjunction with the EREC Monitoring & Assurance team to ensure an active and robust Company compliance program, including oversight and monitoring of program effectiveness.
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Monitors 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.
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Proactively engages and partners with E&C, EREC, Legal and Business colleagues.
Qualifications, skills, and Experience: -
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Bachelor’s degree in Business, Risk Management or Law; advanced degree preferred
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Extensive progressive experience in compliance risk management.
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Demonstrable compliance experience, ideally in a multinational company; pharmaceutical, life sciences or manufacturing background preferred.
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Knowledge of pharmaceutical/ healthcare law, regulations, and codes of conduct
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Practical experience of implementing compliance projects
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Fluency in English (both in oral and written communication)
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Excellent written and spoken communication skills, including strong presentation skills
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Strong stakeholder management and interpersonal skills
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Expertise as to healthcare and/or pharma laws, regulations, standards, codes of conduct impacting compliance program requirements
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Healthcare or pharma compliance program regional standards
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Strong analytical skills with the ability to develop and apply pragmatic solutions to complex compliance / E&C matters
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Self-motivated, self-starter, results oriented
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Commitment to being part of a global team
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Ability to work in a cross-functional, cross-cultural matrixed environment
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Excellent networking skills and ability to influence others to accept practices and approaches, and ability to communicate and influence executive leadership.
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Strong negotiating and drafting skills.
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Strong business acumen and judgment.
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Strong communication and stakeholder influencing skills.
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the
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About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL
Seqirus
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