Risk & Compliance_ Infrastructure/Platform 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 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

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 Validation Lead is responsible for overseeing computer systems validation programs across the organization within a regulated cGMP environment. This individual collaborates with cross-functional teams to ensure compliance with industry standards and regulatory requirements, implements risk-based validation strategies, and oversees validation and testing activities using modern tools and methodologies. This role supports Takeda's mission by delivering high-quality, compliant solutions while guiding and developing validation team members to achieve departmental goals.

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How you will contribute:

• Develop, initiate, and oversee risk-based validation strategies and procedures to ensure compliance with regulatory standards and industry best practices for IT systems and processes.  
• Lead validation planning, execution, and reporting across the organization, including risk assessments, validation deliverables, documentation updates, and driving remediation of issues.  
• Establish, monitor, and report Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs) for validation effectiveness and compliance.  
• Collaborate with business and technology leaders to communicate validation risks and ensure a clear understanding of their impact and required actions.  
• Provide leadership in advancing validation frameworks and documentation processes, aligning with business goals and compliance requirements.  
• Guide and mentor validation team members to develop their expertise and ensure the successful delivery of projects in adherence to Takeda’s compliance standards.
• Continuously improve validation processes by adopting innovative tools and methodologies to enhance efficiency and effectiveness while maintaining regulatory compliance.
• Coordinate with cross-functional teams to ensure a seamless approach to validation and compliance initiatives enterprise-wide.

Skills and qualifications:
As an early-career professional, you handle problems of limited scope and complexity, adhering to established policies and procedures. Your decision-making is within a defined scope, using standardized methods to analyze situations and data. You are developing knowledge of basic principles, theories, and concepts, and beginning to apply industry practices and standards. Typically, this role requires some relevant experience, with contributions mostly related to task-specific activities. Your primary contacts are with your immediate team, and you work under moderate direction and close supervision, following specific, detailed instructions.

•  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
• 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 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. We’re not just transforming our company; we’re 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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