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Job DescriptionAbout the Role
In this role, you will independently manage significant Good Clinical Practice compliance activities across Research and Development. You will provide subject-matter expertise to strengthen inspection readiness, quality-system execution, risk management, and continuous improvement. Working with cross-functional stakeholders, you will help identify, assess, escalate, and mitigate compliance risks while supporting the implementation of the compliance strategy and quality management system. Your work will contribute to consistent procedural compliance, effective risk reduction, and sustainable improvements across Research and Development. You will also lead defined projects and workstreams, influence stakeholders, and support a strong culture of quality and inspection readiness.
How You Will Contribute
- Manage assigned quality-system activities including standards, procedures, change controls, deviations, incident escalation, investigations, and corrective and preventive actions.
- Provide compliance expertise and practical guidance to study teams, process owners, and Research and Development stakeholders.
- Lead quality-event investigations and corrective actions by coordinating root-cause analysis, effectiveness checks, risk escalation, and timely follow-up.
- Coordinate audit and inspection readiness through preparation, document review, request management, stakeholder support, response development, and post-inspection remediation.
- Analyze compliance metrics and trends to identify risks, recommend mitigation actions, and prepare reports for governance forums and leadership.
- Lead defined projects and workstreams while partnering with Clinical Trial Delivery, Medical, Research and Development Quality, and other functions.
- Support continuous improvement by translating audit and inspection lessons into practical, sustainable improvements.
Qualifications
- A bachelor’s degree or equivalent experience.
- At least six years of experience in the pharmaceutical industry and/or a clinical research organization.
- Solid knowledge of clinical trial management and Good Clinical Practice compliance processes.
- Comprehensive knowledge of regulatory requirements governing clinical trials and relevant industry best practices.
- Advanced knowledge of drug development and clinical trial processes, including related standards and documents.
- Experience with clinical development training and process management methods and tools.
- Strong planning, execution, problem-solving, negotiation, collaboration, and communication skills.
- Experience working effectively with stakeholders and teams without direct reporting relationships, using digital tools, Microsoft Office, project management, and presentation software.
Salary range:
267,400.00 PLN - 367,730.00 PLN
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Skills Required
- Bachelor's degree or equivalent experience
- At least six years of experience in the pharmaceutical industry and/or a clinical research organization
- Solid knowledge of clinical trial management and Good Clinical Practice compliance processes
- Comprehensive knowledge of regulatory requirements governing clinical trials and relevant industry best practices
- Advanced knowledge of drug development and clinical trial processes, including related standards and documents
- Experience with clinical development training and process management methods and tools
- Strong planning, execution, problem-solving, negotiation, collaboration, and communication skills
- Experience working effectively with stakeholders and teams without direct reporting relationships
- Experience using digital tools, Microsoft Office, project management, and presentation software
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
Takeda Insights
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
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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