Senior Manager, GCP Compliance
Warsaw, Mazovia Job ID R0192262 Category Quality Subcategory Quality Business Unit Research & Development Job Type Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About 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.
