CSV Manager
- Bangalore, Karnataka
- Permanent
- Full-time
The Digital Risk and Compliance, Manager is responsible for managing the global information security risk program across the organization. This individual will work directly with business leaders to understand security and risk issues, oversee risk management and assessment efforts, and develop effective remediation programs.About the Role
We are seeking a seasoned Validation Manager with deep expertise in Computer System Validation (CSV) and a strong background in Software as a Medical Device (SaMD). This role is critical to ensuring our digital health platforms meet global regulatory standards and deliver safe, effective, and compliant solutions.Key Responsibilities
- Lead CSV activities for systems supporting SaMD and SiMD, ensuring compliance with GxP and data integrity standards.
- Expertise in global regulatory compliance related to SaMD/SiMD, including 21 CFR Part 11, 21 CFR Part 820, FDA SaMD guidelines, and ISO 13485.
- Proven ability to validate commercial software platforms, focusing on data integrity, scalability, and GxP compliance.
- Hands-on experience with real-world evidence platforms, ensuring accurate system validation and patient outcomes enablement.
- Deep understanding of system integration and interoperability testing for digital health and connected devices.
- Strong experience in cross-functional collaboration to validate SaMD/SiMD and align SaMD processes with commercial objectives and market realities.
- Plan, draft, and maintain validation documentation, including validation plans and specification documentation , Validation Summary Report.
- Develop testing protocols such as Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Execute validation tests and compile comprehensive phase reports.
- Evaluate and address validation risks associated with system changes, updates, or implementations.
- Collaborate with external system providers during implementation, ensuring alignment with validation requirements and quality standards.
- Act as a subject matter expert Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746 (EU), Validation of CSV supporting SaMD
- Maintain detailed and up-to-date validation documentation in compliance with regulatory standards and industry best practices.
- Investigate deviations, discrepancies, or non-conformances encountered during validation activities and ensure corrective actions are appropriately implemented.
- Provide training and mentorship to team members and stakeholders regarding validation processes, protocols, and best practices.
- Serve as a go-to expert for validation-related challenges and initiatives.
- Stay informed of industry developments, evolving regulations, and emerging technologies related to validation processes and systems.
- Continuously integrate improvements and ensure alignment with regulatory guidelines.
- 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 validating systems in regulated environments, especially those supporting SaMD.
- Strong knowledge of:
- 21 CFR Part 11, 21 CFR Part 820
- FDA SaMD guidelines
- ISO 13485, EU MDR 2017/745, EU IVDR 2017/746
- Hands-on experience with:
- Real-world evidence platforms
- Data integrity and scalability validation
- System interoperability testing
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork abilities.
- Attention to detail and a commitment to quality.
- Experience with AI/ML-enabled SaMD.
- Familiarity with cybersecurity and privacy compliance in medical software.
- Exposure to global regulatory submissions and lifecycle management.
- Must have experience working in agile environment and use of modern quality tools ( e.g. ( JIRA, Confluence, Qtest, etc)
- Working knowledge of Validations supporting SAMD
- Experience working with virtual teams on a global basis
- In depth knowledge of GxP regulations( such as from FDA, EMA, etc) related to SAMD, IT Systems
- Ability to lead teams in the correct interpretation of regulations
- Good oral and written communications skills, business acumen with problem solving and analytical skills
- 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.
- 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.