Astellas Pharma Senior Director, Compliance Excellence and Transformation Head of Risk Assessment, Monitoring and Investigations in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Senior Director, Compliance Excellence and Transformation Head of Risk Assessment, Monitoring and Investigations opportunity in Northbrook, IL.
Purpose & Scope:
The Senior Director, Compliance Excellence and Transformation Head of Risk Assessment, Monitoring and Investigations serves in a global leadership role as part of Compliance Excellence and Transformation ("CET"). The position provides strategic direction and is accountable and responsible for leading the ongoing development and implementation of universally high standards for the Company's global ethics and compliance risk assessment, analytics, compliance monitoring, hotline reporting and investigations functions. This position will work closely with Ethics & Compliance regional and local personnel and the business, to lead global operational effectiveness, efficiency and consistency in the above areas. The role also encompasses developing strategies, programs, systems tools and resources to support a culture of high performance, continual improvement and successful project execution in the above areas. The Senior Director has accountability and responsibility to ensure that global and regional Operations activities (e.g., regional risk assessment, analytics, compliance monitoring, hotline reporting and investigations) are effectively developed and implemented through a matrixed Ethics & Compliance organization.
Essential Job Responsibilities:
The incumbent will have an excellent track record designing, developing and implementing global risk assessment, analytics, compliance monitoring, hotline reporting and investigations strategy and processes in an Ethics & Compliance function, including with respect to healthcare compliance and market integrity. This position has accountability and responsibility for the following:
- Stewardship of robust three-way communications and collaboration between Ethics & Compliance employees operating at global, regional and local levels. For example, this includes ensuring that there is collaborative development of universally high standards of the compliance programs across divisions with appropriate customization to cater for different regulatory requirements and risk profiles.
- Developing strategy for and implementing a global risk assessment process that is periodically updated to take in to account updated operational data and other information from across functions. Ensure that the risk assessment proactively identifies and prioritizes Ethics & Compliance risks, including but not limited to healthcare compliance and market integrity in close coordination with the global program leads (e.g. ABAC and Privacy leads). Working with regional Heads of Ethics & Compliance to develop and implement plans to mitigate the identified risks.
- Developing a global risk inventory based on input from Regional Heads of Ethics & Compliance, the global ABAC Lead, relevant business stakeholders and external insights / good practice. Developing toolkits to assist in risk assessment implementation and ensuring that the risk assessment informs the nature of the compliance program put in place.
- Designing and implementing a scalable, flexible global monitoring strategy and program to quickly identify and respond to changing or emerging risks as well as address compliance needs before problems become systemic. Continuously improving monitoring capabilities across the globe including creating additional monitoring tools to assist in regional and local execution of monitoring procedures and inform the ongoing assessment of risk.
- Continually improving the strategy for the evaluation/assessment of and evaluating and assessing monitoring and investigation results for global trends. Developing the strategic plan for universally high standards of corrective action plans in collaboration with regional Heads of Ethics & Compliance and the global ABAC Lead (e.g., changes to policies/procedures, guidance, training or other corrective action).
- Continually assessing, critically evaluating and refining the Compliance Excellence and Transformation strategic direction and framework by ensuring that resources are aligned to progressing the maturity and effectiveness of the ethics and compliance program.
- Developing, creating and maintaining a data analytics strategy (in collaboration with IT, Commercial, R&D and other business analytics teams) which supports Ethics & Compliance objectives. Developing a strategy and process for reporting and preparing dashboards/reports of global, regional and local trends from aggregated data from the global ABAC and Privacy Leads and regional and local Heads of Ethics & Compliance.
- Developing strategy for and managing a global reporting and investigations system and process (e.g., maintenance of a global hotline/helpline system and process for reporting, tracking, trending, and investigating compliance concerns worldwide) to ensure that actual and potential compliance concerns are handled in a fair, timely, and comprehensive manner.
- Developing and maintaining a system for reporting global trends. Developing training for appropriate handling of compliance reporting, tracking, intake and investigations.
- Identifying fertile sources of information to formulate Key Performance Indicators ("KPIs" to measure the maturity and effectiveness of the Global Compliance Program.
- Other Ethics & Compliance initiatives deemed necessary to further enhance Astellas' commitment to ethics & compliance.
Responsible for operating within the regional compliance budget, and any applicable project specific budgets.
- Directly reports to the VP, Compliance Excellence and Transformation
- This position develops strategy, designs and implements global compliance risk assessment, analytics, compliance monitoring, hotline reporting and investigations functions in close collaboration with regional Ethics & Compliance Excellence and Transformation employees through a matrixed organization for the efficient and effective implementation of strategy, tools and resources
- Works closely and collaborates with senior leadership of all functions across the company
- Minimum of 10 years' experience in Compliance or related functions (e.g., regulatory, legal, audit, or risk).
- Advanced degree (Juris doctor; Masters; Ph.D) or advanced compliance certifications (CCEP or equivalent).
- Strong expertise in compliance with law, regulations and industry codes relevant to a highly regulated industry. Significant knowledge of the best practices relating to compliance in highly regulated industries. (Pharmaceutical industry experience preferred.)
- Proven ability to lead high-level, broad-based objectives in the context of annual compliance objectives.
- Must be a strong and effective strategic thinker and problem solver, requiring the ability to both recognize and anticipate problems, and also help others develop their own problem solving skills and discipline.
- Ability to interpret rules and guidelines, and ability to conceptualize policies, procedures and controls. Must be able to identify and solve strategic and tactical problems and translate solutions into viable action plans at a global organizational level.
- Ability to self-start and self-direct work in a fast-paced environment.
- Excellent project management skills. Ability to prioritize and work simultaneously on multiple projects, strong attention to detail, and ability to organize and analyze complex information and data.
- Demonstrated experience leading projects and activities in a matrixed, global organization.
- Excellent written and verbal executive-level communication skills.
- Adaptability necessary to work effectively in a sometimes ambiguous, changing, and matrix global environment.
- Exceptional ethics and commitment to integrity, interpersonal skills, professionalism, and collegiality.
- Does not confuse effort for results.
- Tenacity to weather short-term setbacks for long-term advantages.
- Ability to demonstrate sound and independent judgment, prudence and maturity in complex and sensitive cases.
- Client orientation with a constructive approach to resolution of issues. A style which builds alliances within the organization, locally/globally, and/or corporate collaborators.
- Domestic and international travel anticipated (approximately 30%)
- Experience working globally and living and working in another country
- Fluency in second language(s)
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Ethics and Compliance