Risk and Compliance, InfrastructurePlatform Qualification

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 Indias epicenter of Innovation has been selected to be home to Takedas recently launched Innovation Capability Center. We invite you to join our digital transformation 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 Takedas ICC we Unite in Diversity

Takeda is committed to creating an inclusive and collaborative workplace where individuals are recognized for their backgrounds and abilities they bring to our company. We are continuously improving our collaborators journey in Takeda and we welcome applications from all qualified candidates. Here you will feel welcomed respected and valued as an important contributor to our diverse team.

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 Takedas 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)
• Working knowledge of General IT strategy IT infrastructure and systems cloud technology preferable AWS DevOps applications and tools
• 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
• Bachelors 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 care of our people.

• At Takeda you take the lead on building and shaping your own career.

• Joining the ICC in Bengaluru will give you access to high-end technology continuous training and a diverse and inclusive network of colleagues who will support your career growth.

Benefits:

It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:

• Competitive Salary Performance Annual Bonus
• Flexible work environment including hybrid working
• Comprehensive Healthcare Insurance Plans for self spouse and children
• Group Term Life Insurance and Group Accident Insurance programs
• Employee Assistance Program
• Broad Variety of learning platforms
• Diversity Equity and Inclusion Programs
• Reimbursements Home Internet & Mobile Phone
• Employee Referral Program
• Leaves Paternity Leave (4 Weeks) Maternity Leave (up to 26 weeks) Bereavement Leave (5 calendar days)

About ICC in Takeda

• Takeda is leading a digital revolution. Were not just transforming our company; were improving the lives of millions of patients who rely on our medicines every day.
• As an organization we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.

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