Senior Manager, GCP Compliance

Takeda; Warszawa; On-site; PLN 267,000 - 368,000; Full time

Job summary

Takeda in Warsaw, Poland, is seeking an experienced Quality/Compliance professional to independently drive Good Clinical Practice compliance across R&D. You will guide inspection readiness, strengthen quality systems, manage risks, and support continuous improvement while partnering with cross‑functional stakeholders.

You will lead defined projects, coordinate audits, and mentor teams to ensure procedural compliance and timely CAPA execution within a robust quality culture.

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.

Responsibilities

• Manage assigned quality-system activities including standards, procedures, change controls, deviations, incident escalation, investigations, and CAPAs.
• Provide compliance expertise and practical guidance to study teams, process owners, and R&D stakeholders.
• Lead quality-event investigations and corrective actions with root-cause analysis and risk escalation.
• Coordinate audit and inspection readiness through preparation, document review, and response development.
• Analyze compliance metrics and trends to identify risks and prepare governance reports.
• Lead defined projects and workstreams with cross-functional partners.
• Support continuous improvement by translating audit lessons into sustainable actions.

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Project management tools

Presentation software

Job description

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, escalat, 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.

Locations

Warsaw, Poland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time