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 Manager Business Governance opportunity in Northbrook, IL.
Purpose & Scope:
This position supports the AIA Business Governance and Quality Process Lead in establishing and optimizing the quality and risk management systems (policies, SOPs, WPDs monitoring elements, and tools) for Astellas' Advanced Informatics and Analytics function and provides assistance, with other Astellas stakeholder functions. Success in the role will require balancing controls and risk with operational efficiency and effectiveness.
Essential Job Responsibilities:
Works collaboratively with internal and external stakeholders, including AIA Leadership Team and other members of Astellas management, in the development and maintenance of effective and efficient operational controls for the AIA function and initiatives under the responsibility of AIA: compliance with internal company-level and external laws and regulations
Assists with the design, implementation, and performance of the self-monitoring program for the AIA division in relation to controls embedded in AIA-specific Quality Documents family and other AIA processes
Assists with any AIA internal and external audit or compliance requests
Partners with Ethics & Compliance and Legal for the management, resolution, and approval of privacy, compliance, and legal issues impacting the AIA team or Astellas groups partnering with AIA
Creates, implements, and maintains training programs and certifications necessary for adherence to AIA policies, SOPs, WPDs, and contractual requirements that AIA personnel and other business partners must adhere to.
Manages the governance portion of the onboarding, off boarding, maintenance and training of users within the AIA environment
Liaises with AIA Operations and Infrastructure team and Astellas IS to align AIA operational, information systems and data management controls with other processes and controls, both internal to AIA and across Astellas
Develops presentation materials relating to business governance and quality processes for internal presentations to top management and other stakeholders, both internal and external
This position will have significant influence on the day-to-day operations of the global AIA function in terms of governance and quality processes and controls.
May coordinate small group of contract resources
This position reports directly to AIA Business Governance and Quality Process Lead
Minimum BA/BS in relevant field (e.g., finance, accounting, business, computer science, etc.)
Five years pharmaceutical or life science industry experience with preference in Internal Audit, Compliance, or Quality Assurance, legal, IS (security), risk management
Effective written and oral communication and interpersonal skills and strong negotiation, facilitation, and influencing skills with an ability to effectively work across the Astellas groups
Ability to apply industry knowledge and interpretation to anticipate regional and global impact to AIA operations and bring forth for team discussion
Ability to manage multiple areas of responsibility with limited management oversight.
Detail-orientated with strong problem-solving skills
Ability to develop and maintain effective relationships with internal and external stakeholders including Global Astellas entities. This includes independently representing the AIA Business Governance and Quality Process function with such stakeholders.
Proven experience assessing risk and implementing efficient primary and mitigating controls
Internal Audit and/or compliance background
Advanced degree or certification in relevant discipline
Experience with Information Technology controls, data privacy
Experience with real-world and sensitive data assets, PHI, PI, omics, biometrics, etc.
Experience with working in a regulatory environment
Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Northbrook, Illinois, the company serves as the headquarters for the U.S. and employs nearly 1,200 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
Our commitment to changing tomorrow is measured not only by our focus on bringing innovative and effective new medicines to patients and physicians, but also by the importance we place on the impact we can make within the communities where we work and live. Astellas supports many causes and has created Changing Tomorrow Day, an annual, worldwide volunteer event, to demonstrate this commitment.