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Job Description
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
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.
Job Title: Quality Assurance Lead for Plasma-Derived Therapies - Data & Digital Products
About the Role:
This pivotal role focuses on ensuring the quality, reliability, and regulatory compliance of our software solutions within the plasma therapy domain. You will lead a team of approximately 15-20 quality assurance professionals, establish rigorous quality standards, implement robust testing strategies (covering verification, validation, performance, and automation), and ensure our digital products consistently meet the highest standards of safety, efficacy, user experience, and regulatory compliance, with a particular focus on data privacy and security. Your team will support the Business Analysis (BA) team in the preparation and management of validation and system documentation.
As part of the PDT ICC Circle team, you'll play a crucial role in developing the PDT DD&T delivery capabilities, enabling us to design, build, and deploy technical applications that align with the overall PDT business strategy-on time and with uncompromised quality. This role will work closely with the PDT Delivery Leads and Business Analysis Leads across India and globally, aligning with the Quality Assurance chapter of the ICC. You'll report to the PDT ICC Functional Delivery Lead for strategic direction.
How You Will Contribute:
- Develop and implement a comprehensive quality assurance strategy for plasma therapy software, encompassing BECS and SaMD products, by leveraging both GxP and non-GxP standards as appropriate, and ensuring alignment with industry best practices and regulatory requirements.
- Establish quality standards, conduct continuous monitoring and improvement, and manage test cases, test data, and defect processes using a risk-based approach as needed.
- Ensure all software releases meet regulatory standards, including requirements for validation, documentation, and traceability, with particular emphasis on data privacy and adherence to infrastructure security best practices.
- Oversee the creation and maintenance of system documentation for SaMD devices to ensure regulatory compliance, maintaining up-to-date knowledge of IEC 62304, HIPAA, and other relevant regulations.
- Support audit and inspection processes by demonstrating strict adherence to quality procedures and standards, including compliance with data privacy regulations (e.g., PHI, PII, and GxP).
- Define standard training requirements for the QA team; lead, mentor, and monitor team performance.
- Generate and present product quality reports and metrics to leadership.
- Support recruitment processes, including staff training and development.
- Proactively foster strong partnerships across teams and stakeholders to ensure alignment with quality requirements and address any challenges.
- Implement observability within testing processes to proactively identify, track, and resolve quality issues, contributing to sustained high-quality performance.
- Work closely with product team to monitor data quality, integrity, and security throughout the product lifecycle, implementing data quality checks to ensure accuracy, completeness, and consistency.
- Apply risk management methodologies where applicable to enhance quality processes and mitigate potential quality risks.
- Publish quality metrics and collaborate with product and quality stakeholders in performing quality retrospectives to drive defect reduction best practices
Minimum Requirements/Qualifications:
- 8+ years of experience in the life sciences industry, with a strong understanding of regulatory and compliance requirements and experience supporting audits and inspections.
- Excellent leadership skills and a proven experience of leading medium size teams of QA professionals.
- Knowledge of GxP-compliant systems and Software as a Medical Device (SaMD) standards.
- Proficient in Software GxP validation processes and documentation.
- Relevant certifications, such as ISO 13485, HIPAA, or IEC 62304.
- Familiarity with audit compliance processes (e.g., FDA 510k).
- Expertise in test automation (using tools e.g., Tosca, WebDriverIO) and performance testing (using tools e.g., JMeter, Octoperf, BrowserStack).
- Strong understanding of end-to-end SDLC and design control across different QA phases, including the Stage Gate Process and exit criteria for each phase, as well as the required documentation and SLAs needed to ensure program timelines are met.
- Experience with embedded systems, web applications, mobile apps, data analytics platforms, and data science solutions.
- Skilled in data quality checks and validation to ensure accuracy, completeness, and consistency.
- Experience with cloud environments (e.g., AWS) to support validation and performance testing in cloud-hosted applications.
- Familiarity with tools such as qTest and Jira.
- Experience working in an Agile environment (eg. Scrum or SAFe)
Preferred Requirements:
- Certification in Quality Assurance (e.g., CQE, CSQA) and testing (e.g., ISTQB).
- Knowledge of testing REST API (eg. using SOAP UI, Postman), databases, web-hosted applications, and containerization.
- Experience with scripting and programming languages (eg. Python, SQL, Java) and familiarity with AI/ML applications in healthcare settings.
- Exposure to AI and related tools/technologies
- Adaptability to operate effectively in a diverse business environment with cultural considerations to support global collaboration across regions.
- Exposure to validation life cycle management and associated tools like ValGenesis or Vera is a plus
WHAT TAKEDA ICC INDIA 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
- Health & Wellness programs including annual health screening, weekly health sessions for employees.
- Employee Assistance Program
- Broad Variety of learning platforms
- Diversity, Equity, and Inclusion Programs
- No Meeting Days
- Reimbursements - Home Internet & Mobile Phone
- Employee Referral Program
- Leaves - Paternity Leave (4 Weeks), Maternity Leave (up to 26 weeks), Bereavement Leave (5 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.
#Li-Hybrid
Locations
IND - Bengaluru
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Top Skills
What the Team is Saying
What We Do
We strive to transform lives. While the science we advance is constantly evolving, our core purpose is enduring. For more than two centuries, our values have guided us to do what’s right for patients and for society.
We know that changing lives requires us to do things differently. We start by listening to and addressing what really matters to patients, the people who love them, and those in the healthcare system who provide care. And that’s what inspires us all to be bold, push boundaries and set new standards that open up greater opportunities. Join us in our effort to discover, develop and deliver new treatments to patients.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Takeda's hybrid policy varies by role. Be sure to ask your recruiter about the requirements for the role that you are applying for.
