Risk & Compliance_ Infrastructure/Platform Qualification
- Bangalore, Karnataka
- Permanent
- Full-time
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
- Certified Information System Auditor (CISA) with a focus on IT compliance and audit processes.
- Understands IT Risk Management principles and applies them under guidance.
- Familiar with Regulatory Compliance including Sarbanes-Oxley Act and ISO/IEC 27001 standards.
- Knowledgeable about Payment Card Industry Data Security Standard and its application in IT security.
- Capable of conducting basic risk analysis following established guidelines.
- Experienced in System Development Lifecycle Methodology, particularly in secure software development.
- Understands DevSecOps practices and their importance in integrating security within DevOps processes.
- Skilled in Identity & Access Management, ensuring proper access controls are in place and managed effectively.
- Aware of Security Standards & Practices and their application in protecting information assets.
- Knowledgeable in Information Architecture and its role in organizing and managing data.
- Applies basic writing skills for clear communication, adhering to templates and guidelines.
- Follows established procedures for regulatory compliance with a basic understanding of the underlying principles.
- 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.
- 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).
- 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)
- 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.