Manager, Data Integrity QA (DIQA)

Description 【募集の背景 / Purpose & Scope】 Assist in executing the Data Integrity Quality Assurance (DIQA) compliance and oversight program, including compliance gap assessments and process improvement initiatives. Ensure consistent application of Data Integrity regulations and guidelines to GxP data for clinical development and commercial operations, ensuring compliance with global Astellas standards and regulatory requirements. Oversee study-specific software system builds for clinical study operations (e.g., IRT, ePRO, eCRF) and review IRT / eCOA User Acceptance Testing (UAT) documents for procedural compliance. Execute process improvements and support new technology initiatives. Contribute to the development and execution of the QA mission, objectives, and strategic plan. 【職務の内容 / Essential Job Responsibilities】 （雇入れ直後）

• Responsible for assisting in the execution of the DIQA compliance oversight program to oversee compliance to Data Integrity regulations and guidelines.
• Executes computerized systems validation oversight pertaining to clinical study operations, including reviewing, and approving computerized system validation documentation for compliance with Astellas policies and procedures. Reports status of validation projects to management.
• Supports DIQAs oversight of computer system validations and User Acceptance Testing of study specific software system builds for systems used for clinical study operations of Interactive Response Technology (IRT), electronic Patient Reported Outcomes (ePRO), and electronic Case Report Forms (eCRF) including facilitating resolution of any potential compliance risks that arise during a study.
• Executes scheduled periodic reviews of IRT / eCOA UAT documentation for study specific GxP regulated systems to ensure systems are maintained under control and remain in a validated state. Reports required revalidation / remediation activities and ensures activities are completed.
• Responsible for participating in the execution of the DIQA internal and vendor audit program to assess Astellas internal processes and computer software vendors and computer related service providers utilized by Astellas.
• Responsible for performing assigned DI compliance assessments, audits, reporting audit findings, and working to ensure appropriate audit response and corrective actions are provided by the business.
• Under the direction of management, works closely with Astellas business function representatives, including Data Sciences, Clinical Sciences, Digital X, and commercial manufacturing to ensure process control and improvements to ensure Data Integrity compliance and process improvement.
• Manages and executes assigned process improvement initiatives related data integrity control processes, and regulatory compliance assurance processes throughout Astellas. Manages multiple assigned projects concurrently. Collaborates with key stakeholders and functional area customers across the Astellas organization for process improvement initiatives and to communicate compliance issues to management.
• Provides QA oversight of assigned projects to assure quality of output as well as compliance with standards, policies, procedures and regulations, including the global Electronic Records / Electronic signatures regulations (e.g. 21 CFR Part 11) and Data Integrity regulations and guidance.
• Utilizes tools to track and trend compliance metrics, and quality related issues; to ensure that Astellas systems and procedures comply with internal company (global, regional, and site) and external regulatory agency standards for compliance and validation. Reports project and program status to QA management.
• Participates in the execution of a comprehensive risk management process and risk-based approaches related to data integrity process controls within Astellas.
• Contributes to and manages the administration of departmental controlled documents (i.e., policies, SOPs, WPDs / WIs, Forms, etc.) as necessary. Conducts and coordinates compliance, and quality training as needed. （変更の範囲） 会社内での全ての業務 【就業環境に関する要件 / Specific Physical or Environmental Requirements】 At Astellas we recognize the importance of work / life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. 【応募要件 / Qualifications】 ＜必須 / Required＞
• Bachelor’s degree or equivalent with 2 years of industry experience, including within Quality Assurance.
• Must demonstrate strong communication, writing and interpersonal skills and the ability to interface across multiple departments and external stakeholders.
• Basic 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.
• Basic knowledge of global industry standards and regulatory requirements for software development, computer system validation, data integrity and Electronic Records and Electronic Signatures regulations. Experience in these disciplines in the pharmaceutical industry.
• Familiarity with GxP 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.
• 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.
• 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.
• Excellent oral and written communication as well as presentation skills.
• Ability to proactively predict and resolve complex problems, think strategically and tactically, execute solutions to complex problems. Able to generate insights and leverage learnings at the individual, team and functional level.
• Basic planning and organizational skills and experience managing multiple priorities simultaneously.
• Domestic and international travel of 5-10% is required.