Description
Purpose & Scope
Responsible for managing and executing the Technology and Data Quality Assurance (TDQA) audit and validation oversight programs related to regional Astellas Information Systems processes for computer systems, technology solutions, clinical and commercial systems, data integrity processes, and related process improvement initiatives within QA. Provides operational management to drive consistent cGxP compliance and validation approaches to ensure compliance with Astellas standards, policies, and procedures. Ensures compliance with global Electronic Records / Electronic signatures regulations and related cGxP regulatory requirements. Responsible for managing the TDQA audit program related to audits of vendors, service providers, and internal processes in support of computerized system validations for new system implementations, system upgrades, change controls, and periodic reviews for computer systems. Develops, facilitates, and implements process improvements and supports new technology initiatives as Astellas continually invests in new technology solutions and computerized systems. Contributes to the development, implementation, and successful execution of the QA mission, objectives and 3-5 year strategic plan.

Essential Job Responsibilities
1. Responsible for operationally managing, coordinating, planning, and administering the TDQA program to oversee the computerized systems validation program, and ensuring reviews of computerized system validation documentation is completed to ensure compliance with Astellas policies and procedures. Reports status of validation projects to management.
2. Responsible for operational management, planning, and administration of the TDQA internal and vendor audit program related to computer software providers and computer related service providers utilized by Astellas. Responsible for scheduling and performing audits. Manages internal and external resources to perform audits. Reports status of audit program to management. Generates trend reports of audit findings for management reviews.
3. Assists TDQA management to plan and manage internal and external resources to execute the TDQA validation oversight and audit programs. Interacts with functional teams to assist QA management to identify QA activities and resources necessary for review and support of project-related initiatives. Manage programs and resources necessary to support assigned projects.
4. Identifies, develops, facilitates, and manages process improvement initiatives related to electronic system development life cycles, validation processes, IT systems/processes, data integrity control processes, and regulatory compliance assurance processes throughout Astellas. Manages multiple projects concurrently. Collaborates with key stakeholders and functional area customers across the Astellas organization for process improvement initiatives.
5. Serves as QA representative on assigned project teams associated with software validation projects and process improvement initiatives to provide guidance, direction, and support regarding quality assurance and regulatory compliance, to resolve compliance issues, report to management, and to ensure completion of quality related action items.
6. Ensures and facilitates compliance with global Electronic Records / Electronic signatures regulations (e.g. 21 CFR Part 11). Provides quality and compliance guidance in areas of continuous improvement, innovation, and validation. Collaborates, advises and provides consultation on quality matters to individuals, study/core teams, and functional management teams across the Astellas organization.
7. Assists management for development, coaching, mentoring and support for TDQA resources. Develops staff to serve as QA representatives on assigned project teams to provide direction regarding quality and compliance, to communicate compliance issues to management and to oversee completion of quality related action items.
8. Manages QA oversight of validation projects related to specific products to assure quality of output as well as compliance with standards, policies, procedures and regulations. Assists QA management to assess and ensure regulatory inspection readiness. Supports management in presenting and defending validation strategies during regulatory authority and 3rd party inspections.
9. Develops tools to track and trend compliance metrics, validation activities and issues; and assures that Astellas systems and procedures comply with internal company (global, regional, and site) and external regulatory agency standards for compliance and validation.
10.Participates in the development of a comprehensive risk management process related to computerized systems validation activities within Astellas.
11.Authors, revises, and performs maintenance and administration of departmental quality documents (i.e., policies, SOPs, WPDs/WIs, STLs, etc.) as necessary. Conducts and coordinates validation, compliance, and quality training as needed

Compliance

• Embed Compliance Culture across all Regions of the business ensuring Integrity in Action is actively applied in all initiatives.
• Ensure Quality Assurance Function(s) strictly adopt a culture of ethics and compliance, leading by example and appropriately challenging non-compliance.
• Ensure adherence to Astellas policies relating to Ethics and Compliance standards and interactions with Healthcare Professionals (HCPs), Healthcare Organizations (HCOs) and Patient Organizations (POs).
• Mandatory Compliance requirements:
• To be aware of Astellas' Group Code of Conduct and associated policies and procedures and other applicable laws, codes and regulations.
• Clarify and seek guidance as required, and raise any concerns, in a timely manner, with relevant manager, which may include reference to the Ethics and Compliance Team and/or Ethics and Compliance Helpdesk.
• Undertake and comply with relevant mandatory Ethics and Compliance training and updates to maintain personal awareness; all training to be undertaken in a timely manner.
• Be aware of and comply with, the Astellas Way and Astellas Competencies, in terms of expected Values and behaviors, in addition to Astellas' HR policies, procedures and guidelines.

Quantitative Dimensions
1. Generates monthly and ad hoc TDQA metrics reports of quality and compliance trends of document reviews and conducts an analysis of these metrics on a periodic basis for QA management and the IS organization.
2. Reviews and approves several hundred system development life cycle and computer system validation documents per year.
3. Leads or participates in and reports 5-15 internal and vendor audits per year

Organizational Context
1. Reports to the Director, Technology and Data Quality Assurance.
2. Coordinates activities of 2-3 (Associate) Managers within TDQA and contract/consultant resources utilized by TDQA.
3. Represents TDQA on 10-20 system development life cycle and validation project teams per year.
4. Peers include operational levels in Clinical QA, Technology and Data QA, Data Integrity QA, and Quality Systems QA, Quality Services, and PV QA across the regions comprising Quality Assurance.
5. Collaborates, advises and provides consultation on quality matters to individuals, study/core teams, and functional management teams across the Astellas organization.
6. Collaborates directly with QA operational and management members, QA staff, and various levels within Astellas business functions that require support from TDQA.
7. Functions as the QA main point of contact for assigned teams and functional areas.

Qualifications
〈Required〉
1. Bachelor of Arts/ Bachelor of Science degree or equivalent science related
2. Minimum 5 years experience in the pharmaceutical industry
3. Minimum of 5 years experience in quality assurance in the pharmaceutical industry
4. Minumum 5 years experience performing or overseeing in software/system development life cycle and computer sytem validation.
5. Minimum of 5 years project management experience, preferably in a multicultural, global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills.
6. Proficiency in Microsoft Office
7. Domestic and international travel of 15-20% is required.
8. Fluent in written/read and spoken business Japanese
Skill and Competency
1. In-depth knowledge of GxP regulations and computerized systems in GxP regulated environments, preferably for pharmaceuticals, relating to product development, combined with broad knowledge of quality principals and industry trends.
2. In-depth knowledge of global industry standards and regulatory requirements for software development, computer system validation, and Electronic Records and Electronic Signatures regulations. Experience in these disciplines in the pharmaceutical industry.
3. Regulated (FDA, EMA, MHLW, ISO, or other) computerized systems auditing experience in a pharmaceutical manufacturing or clinical development environment required. Ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies.
4. Experience in developing and maintaining effective relationships with internal and external stakeholders for process improvement and issue resolution project teams. Collaborative skills to facilitate, manage, and work within project teams across departments and global organizations.
5. Successful use of experience and knowledge in developing approach for managing multiple areas of responsibility. Has developed / executed quality strategies with management guidance. Can make decisions for the department in his/her area of quality expertise with limited management oversight.
6. Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration. Forges strong working relationships with all colleagues and stakeholders.
7. Excellent oral and written communication as well as presentation skills.
8. Demonstrated ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across the global organization. Able to generate insights and leverage learnings at the individual, team and functional level.
9. Strong planning and organizational skills and experience managing multiple priorities simultaneously.
10. Strong leadership skills; communicates and demonstrates vision and commitment.
11. Demonstrated experience in managing and coaching individuals and teams.
〈Preferred〉 Advanced degree in related disciplines. Minimum 2 years of experience managing staff (contractors/consultants, full time employees or both)

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