Platform Regulatory Compliance & QA Enablement Lead

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Job Description

Platform Regulatory Compliance & QA Enablement Lead

The Future Begins Here

At Takeda, we are creating a future-ready organization that uses data and digital to meet the needs of patients, our people, and the planet. We need your help to make this happen. Join our new Innovation Capability Center (ICC) in Bratislava, Slovakia.

In this role at our state-of-the-art center, you will have the opportunity to grow your skills and create solutions that will benefit patients around the world. Become the heart of our internal innovation engine.

At Takeda we unite in diversity

Takeda is committed to creating an inclusive workplace, where individuals are recognized for the diverse backgrounds and abilities they bring to our company. We are continually improving workplace experience and accessibility for everyone, and welcome applications from all qualified candidates. Here, you will feel welcomed, respected, and valued as an important contributor to our Team.

The Opportunity

The Platform QA & Compliance Implementation Lead ensures that Takeda’s digital health platforms are delivered with the right processes, tools, and resources to meet regulatory and quality goals across both non-SaMD and SaMD products. This is a hands-on technical role embedded within the Digital Health Platforms organization, focused on enabling development teams to build stable, compliant, and audit-ready products.

While embedded in the platform team, the role collaborates closely with ICSS/Chapter-aligned engineering teams to ensure consistent implementation across squads. It works directly with developers, architects, and QA/RA experts to implement platform-wide testing, reliability, and documentation practices. The role owns reusable tooling for validation and traceability, supports audit readiness, and helps teams automate recurring regulatory steps. Training and enablement are core to this role, ensuring that quality and compliance are embedded in day-to-day development workflows.

Responsibilities

Platform Implementation & Enablement

• Define and maintain platform-wide QA, performance, and compliance processes

• Set up and monitor testing and reliability practices across development teams

• Own and continuously improve reusable tooling for validation, traceability, and documentation (e.g., templates, checklists, automation scripts)

• Support SaMD documentation and audit readiness in partnership with QA/RA

• Identify and automate recurring regulatory approval steps

• Train teams on quality and compliance tools and workflows

• Tailor QA and compliance processes to the lifecycle stage of each platform component—from early prototyping to production deployment

Cross-Functional Collaboration

• Coordinate with Architecture and Development leads on test coverage and reliability

• Ensure QA practices are aligned with platform architecture and development standards

• Act as a central point of contact for regulatory and quality-related implementation support

Skills and Qualifications

Required

• Bachelor’s degree in computer science, software engineering, or a related technical field

• Minimum 5 years’ experience implementing QA and validation processes in software development environments

• Experience with automated testing frameworks, performance monitoring tools, and traceability systems

• Strong understanding of regulatory requirements for digital health products (SaMD and non-SaMD)

• Proven ability to translate compliance needs into developer-friendly tools and workflows

• Experience supporting audit readiness and validation documentation

• Fluent in English

• Comfortable working directly with developers, architects, and QA/RA teams in fast-paced delivery environments

• Hands-on experience with QA tooling, validation workflows, and performance testing in software environments

• Strong understanding of digital health regulatory frameworks (SaMD and non-SaMD)

• Ability to embed validation and traceability into CI/CD pipelines and developer workflows

• Skilled in translating regulatory requirements into practical, developer-friendly processes

• Comfortable working across technical and non-technical teams to ensure compliance is built into delivery

Preferred:

• Experience in life sciences or healthcare technology

• Familiarity with SaMD development and validation processes

• Experience with CI/CD pipelines and test automation in regulated environments

• Knowledge of Takeda’s digital health platform priorities

What Takeda Can Offer You

At Takeda, you may build your career, while contributing to better people’s lives. Expect trust driven culture built around Integrity, Fairness, Honesty and Perseverance. Joining ICC will give you access to high end technology, training and colleagues who will support your growth.

Salary

As a motivated employee, you should be compensated appropriately. The minimum salary for this position is € 5400 per month (full time), but your final remuneration package may be higher depending on your qualifications and experience.

Benefits

Here are a few benefits our employees are enjoying at Takeda. To get a full picture of what we are offering, follow this link.

• Cafeteria
• Medical - High standard medical care
• Bridge days
• Summer Hours
• Multisport Card

Your application and any and all conversations that occur with the recruiter, HR, and the hiring manager as part of that application will be treated in the strictest confidence.

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