Senior GCP Compliance Lead | Audit Readiness & QA

Takeda Pharmaceutical Co.; Województwo mazowieckie; On-site; PLN 267,000 - 368,000; Full time

Job summary

Takeda Pharmaceutical Co. in Warsaw, Poland, is seeking an experienced quality/compliance professional to manage significant GCP compliance activities across R&D.

You will provide subject-matter expertise to strengthen inspection readiness, quality-system execution, risk management, and continuous improvement. You will lead quality-event investigations, coordinate audits, and collaborate with Clinical Trial Delivery, Medical, and other functions to drive sustainable improvements.

Qualifications

• A bachelor’s degree or equivalent experience.
• At least six years in pharma/ CRO.
• Solid knowledge of clinical trial management and GCP.
• Regulatory requirements for trials and industry best practices.
• Advanced drug development and trial process knowledge.
• Experience with clinical development training and process tools.
• Strong planning, execution, problem-solving, and communication.
• Experience working with stakeholders across functions using digital tools.

Responsibilities

• Manage quality-system activities including changes, deviations and investigations.
• Provide compliance guidance to study teams and stakeholders.
• Lead quality-event investigations and corrective actions.
• Coordinate audit and inspection readiness.
• Analyze compliance metrics and trends for governance forums.
• Lead defined projects with cross-functional partners.
• Support continuous improvement from audit insights.

Skills

GCP compliance

Regulatory knowledge

Project management

Stakeholder management

Communication

Education

Bachelor’s degree or equivalent

Tools

MS Office

Job description

Takeda Pharmaceutical Co. in Warsaw, Poland, is seeking an experienced quality/compliance professional to manage significant GCP compliance activities across R&D.

You will provide subject-matter expertise to strengthen inspection readiness, quality-system execution, risk management, and continuous improvement. You will lead quality-event investigations, coordinate audits, and collaborate with Clinical Trial Delivery, Medical, and other functions to drive sustainable improvements.