Digital and Business Compliance Analyst

3日前

Chuo Astellas Pharma Inc. Permanent
Description 【募集の背景 / Purpose & Scope】 As individual contributor of a team of individuals in a specific area of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Our agile operating model consists of two key components – Digital Capability and Digital Execution. Digital Execution is about aligning multiple missions around business goals and facilitating collaboration on a larger scale. Digital Capability focuses on the growth and development of individuals within a specific expertise area. This dual structure enables us to scale agile practices efficiently while maintaining a focus on both product development and individual skill enhancement. A Digital and Business Compliance Analyst plays a crucial role in the system development lifecycle, focusing on ensuring the quality, reliability, and performance of software products within agile development environments. This role involves integrating QA and validation processes into the agile workflow, working collaboratively with cross-functional teams to identify and address potential issues early in the development cycle. The Digital and Business Compliance Analyst applies both manual and automated testing strategies to ensure that products meet all functional and non-functional requirements before release. Validation in Agile methodologies is a critical process that ensures the software product meets business needs and user expectations. It involves continuous verification of the product against requirements throughout the development lifecycle. This approach aligns with the Agile principle of delivering working software frequently and emphasizes the importance of customer collaboration and responsiveness to change. You will be at the forefront of implementing innovative solutions and will have the opportunity to work on cutting-edge technologies in your field. 【職務の内容 / Essential Job Responsibilities】 (雇入れ直後) 1.


Agile Collaboration:
Actively participate in agile ceremonies such as sprint planning, daily stand-ups, sprint reviews, and retrospectives to integrate QA and validation perspectives from the outset of project planning through to execution


2Continuous Testing:

Implement continuous testing strategies that align with agile methodologies, ensuring that testing is an integral part of the development process from the beginning to the end of each sprint.

3.System Life Cycle (SLC) Review – Review and approval of System Lifecycle (SLC) deliverables as part of the change management process.

4.


Quality Metrics and Reporting:
Track and report on key QA metrics, such as CAPA. Use this data to make informed decisions about risk and quality. 5.


Defect Management:
Identify, document, and manage defects discovered during testing. Work closely with developers to prioritize defect resolution and ensure issues are resolved in a timely manner. 6.


Stakeholder Communication:
Communicate effectively with project stakeholders, including product owners, developers, and business users, to ensure a clear understanding of SLC deliverables, computer systems validation best practices


7Process Improvement:
Continuously evaluate and improve QA and validation processes to enhance team agility and software quality. Support all initiatives related to quality and validation. 8.


Audit:
Support all audits and inspections around computer systems validation (変更の範囲) 会社内での全ての業務 【Required Qualifications】

  • Bachelor's degree in relevant field, e.g., Computer Science, Data Science, Business Administration.
  • Minimum 5 years of experience in compliance, quality assurance and validation of business applications in an agile environment.
  • Strong analytical and problem-solving skills.
  • Ability to work effectively in a team environment.
  • Excellent communication skills, both written and verbal.
  • Strong background in Computer Systems Validation and System Development Life Cycle.
  • Relevant experience working in pharma sector for at least 5 plus years.
  • Ability to communicate confidently in English, speaking, listening, and writing.
【Preferred Qualifications】 Any of the below additional qualifications will be regarded as a plus:


  • Certifications in Agile delivery methodologies (e.g., SCRUM, SAFe)

Agile Champion:
Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery 【Working Environment】

  • This position is remote and is based in Japan.
  • 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.

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