Risk and Compliance, Infrastructure/platform Qualification

**The Future Begins Here**

At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet.

Bengaluru, the city, which is India’s epicenter of Innovation, has been selected to be home to Takeda’s recently launched Innovation Capability Center. We invite you to join our digital transformation journey. In this role, you will have the opportunity to boost your skills and become the heart of an innovative engine that is contributing to global impact and improvement.

**At Takeda’s ICC we Unite in Diversity**

**About the role**:
The Digital Risk and Compliance, Sr. Analyst is responsible for managing the global information security risk program across the organization. This individual collaborates with business leaders to understand security and risk issues, oversees risk management and assessment efforts, and develops effective remediation programs. This role supports Takeda's mission by ensuring the security and compliance of IT systems and processes.

**How you will contribute**:

- Develop, initiate, and maintain global policies and procedures for the operation of the compliance program to prevent illegal, unethical, or improper conduct with IT systems and processes
- Lead and govern the measurement and reporting of risks across the organization, including documentation updates, scoping, assessments, management reporting, and driving remediation of issues
- Establish, monitor, and report KPIs and Key Risk Indicators
- Communicate and present key security risks at various levels, including business and technology leaders, to ensure a clear understanding of these risks
- Provide leadership in maturing the global information security risk management program, including enterprise security reporting and metrics processes to meet the ongoing needs of the business
- Organize and host internal and third-party audits, providing audit oversight and managing post-audit corrective actions
- Coordinate with other groups responsible for risk management areas

**Skills and qualifications**:

- Must have experience working in agile environment and use of modern quality tools ( e.g. ( JIRA, Confluence, Qtest, etc)
- Experience working with virtual teams on a global basis
- In depth knowledge of GxP regulations( such as from FDA, EMA, etc) related to IT systems and Infrastructure.
- Ability to lead teams in the correct interpretation of regulations.
- Good oral and written communications skills, business acumen with problem solving and analytical skills
- ** Key Responsibilities**:

- Provides overall IT infrastructure qualification guidance and support to the Agile Teams (E.g., product owners, SMEs, testers, Developers, QA) for projects handled via agile infrastructure qualification and, similarly to project teams if project is managed via waterfall method.
- Responsible for defining the risk-based qualification strategy to ensure fulfillment of intended use and conformity with applicable Takeda governing SOPs and regulatory requirements.
- Responsible for verifying that right processes and procedures are applied, as defined in the Takeda QMS, I.e., Infrastructure Qualification, change and CMDB, third party assessments, etc
- Create qualification plans and qualification summary reports.
- Review qualification deliverables and approve per governing processes, e.g., IQOQ
- Liaise with entire cloud team, QA, C&DT, Application Teams, and other related functions.
- Lead Infrastructure qualification related training activities for product and project teams.
- Provide regular reports on project/operational support related to infra qualification activities.
- Provide QMS support in development and maintenance of Infra and platform processes, Work instructions, Forms, etc

**Qualifications**
- 8-10 years of experience in a similar role
- Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences).
- Proven experience infrastructure qualification and computer system validation.
- In-depth knowledge of relevant regulations, guidelines, and industry standards related to Infrastructure qualification, CSV, data integrity, and computerized systems (e.g., GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition, 21 CFR Part 11, 21 CFR Part 820, EU GMP Annex 11).
- Knowledge and hands on experiencing qualifying cloud platforms and solutions ( E.g. AWS, Azure, etc)
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork abilities.
- Attention to detail and a commitment to quality.
- Plan, draft, and maintain validation documentation, including validation plans and specification documentation for laboratory and manufacturing systems (e.g., LIMS, Open Lab).

**WHAT TAKEDA CAN OFFER YOU**:

- Takeda is certified as a Top Employer, not only in India, but also globally. No investment we make pays greater dividends than taking good