Global Technology Principal: Manage Application Lifecycle for Global Systems (Veeva Vault,

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

Ensures the alignment of existing information systems with business requirements across Astellas Value Chain including Research (DDR), Medical & Development (M&D), Pharmaceutical Technology (PT), and Quality Assurance (QA) globally for a certain function in collaboration with Relationship Management (RM) and Programs & Projects (PP) Teams. Advises the organization in the definition of new or improved technologies related to information management in support of business change to enhance the value of information to the business for that function.

Essential Job Responsibilities:

1. Builds strategy for existing R&D Partner system landscape

• Actively contributes to application lifecycle management strategy for IT systems owned by R&D Partner group;

• In close collaboration with Astellas Business, RM Team and other IS stakeholders (Service Delivery management, Data Applications and Architecture, Vendor Management), be responsible for creating and maintaining a 3-5 year strategic technology domain roadmap which will enable one or more core capabilities for R&D Partner business functions;

• Be responsible for executing application life cycle strategy and roadmap for designated subset of R&D Partner systems;

• Be responsible for execution of critical IT projects in assigned areas;

• Assists RM Team by providing relevant technology and/or domain expertise.

1. Drives operational excellence in supporting the existing system landscape

• Pro-actively challenges the organization and key stakeholders (Business Owners, Business Relationship Managers) on opportunities to increase the strategic value of the overall system portfolio i.e., the ratio business value and total cost of ownership;

• For the assigned technology domain, drives Operational Excellence and cost reductions through process standardization, better system utilization, right-sizing of IT service level agreements and license contracts.

1. Drives adherence to IT quality- and compliance standards

• For the assigned technology domain, manages and maintains alignment with the Astellas security, quality, applications and infrastructure standards during the full application life cycle;

• Be responsible, as system owner, for maintaining relevant IT systems in a compliant and/or validated state;

• Be responsible, as system owner, for regular communications to RM team and Process Owners on the support processes (incident-, change- and problem management) and status (trends in volume and/or performance).

• Be responsible, as system owner, for availability, accessibility and security of systems which are part of the assigned portfolio.

• Be responsible for inspection and audit-readiness of assigned system portfolio.

• As system owner, keeps the system information up to date in relevant repositories (ex. Application; Incident; Change Control).

• For relevant systems, manages the contracts (licenses, support, maintenance) with service providers as per shared services best practices.

1. Provides Technology Leadership to Astellas R&D Partner business functions

• Provides thought leadership to internal IT and Business communities on dedicated technology domain which enables core capabilities for customers in R&D Partner business areas.

• For these technologies builds, maintains and shares expertise which is widely recognized in Astellas as well as by peers within the Industry.

• Builds relevant domain expertise by means of external focus, networking with external and/or internal specialists and a solid understanding of R&D business needs.

• For these technologies be responsible to create, maintains and communicates 3-5 year roadmaps for core technology capabilities.

• Manages the portfolio of IT delivery projects associated with these technology domains.

• Provides technical consultancy to project discovery and delivery teams and active participation in project steering teams.

• Influence's decision making processes in IS and/or global R&D Partner business areas through active promotion of technology-driven innovation based on relevant business cases and convincing proof-of-concepts;

• Promotes a culture of innovation by means of actively soliciting ideas, support enablement and implementation.

1. Be responsible for initiating IT projects within the assigned technology domain

• Be responsible for the initiation of projects in the assigned technology domain: create business case, vendor selection process (RFI/RFP), required assessments (privacy, cloud and security), project- and budget approval process.

• For projects which will be executed by the program- and project delivery team, be responsible for hand-over of all required deliverables and required information.

• Supports PP Team to manage IT projects initiated by RM Team by providing relevant technology/domain expertise.

1. Executes IT projects within the assigned technology domain

• Be accountable for the execution of all projects in the assigned technology domain and portfolio.

• Provides Oversight and guidance to the project team.

• Be responsible for the execution of a subset of projects in the assigned technology domain and portfolio.

• Participates in relevant steering committees and/or program PMO teams.

• For new, relevant R&D Partner IT solutions, be accountable for a knowledge transfer from the project team to the operational support teams.

1. Manage staff as appropriate

• May manage team up to 5 individuals.

• Provides guidance to (Senior) Managers in the Application Life Cycle Management Team by providing domain-level expertise.

1. Oversees the services provided by strategic application support vendors and specific support vendors (e.g., cloud vendors) for relevant technology domain

• Escalate repeated non-conformance to Application Life Cycle Management Lead.

Quantitative Dimensions:

1. Customer base relates to a certain business area or areas (ex. development or research).

2. R&D Partner business functions globally within the business area or areas including Research, Medical and Development, Technology, and Quality Assurance.

3. May include departments in one or more of Astellas affiliates globally using one or more systems within the business area.

4. Manages and be accountable for a significant investment IT project budget of up to 3 Million USD/EUR or 300 Million JPY in the assigned technology domain.

Organizational Content:

Reporting Line:

1. Reports to Application Life Cycle Management Lead or higher.

2. Business areas may include:

3. Research

4. Development

• Medical (Medical Affairs, Regulatory Affairs, Clinical & Research Quality Assurance, and Pharmacovigilance)

1. M&D cross-functional functions

2. Pharmaceutical Technology

3. Quality Assurance

• Corporate functions

1. Manages the budget (>1 M USD) to support system base operations.

2. Part of the API Information Systems Department.

3. Manages indirect reports and contractor/consultant relationships as appropriate approximately up to 5 individuals.

Qualifications

Required

Training/Competencies:

1. Masters University degree or acquired by education and/or work experience in IT, business administration or equivalent.

2. Fluent English (verbally and written).

3. Excellent negotiation and influencing skills.

4. Be stress-resistant and analytical.

5. Demonstrated learning ability and ability to acquire new skills as part of the job.

6. Well-developed collaborative social skills.

Experience

1. Minimum of 10 years of relevant experience

2. Over 5 years' experience in Pharmaceutical (R&D) environment.

3. Over 3 years' experience in line management.

4. Over 7 years' experience in project management with extensive knowledge applying project management or system development methodologies.

5. Experience with architecting and designing software solutions

6. Experience as a database administrator, programmer, report builder or similar is desired.

7. Experience in managing vendors (application vendors and service providers).

8. Knowledge of regulatory requirements concerning GxP applications, GAMP5 and 21 CFR Part 11.

9. Knowledge of relational databases (Oracle, MS SQL) is desired.

10. Knowledge of interfaces and middleware solutions is desired.

Benefits

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Referral bonus program

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.

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Category Information Systems

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans