GCP Compliance Lead - Quality & Inspection Readiness

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

Job summary

Takeda Pharmaceutical Co. in Warsaw, Poland, seeks a Quality & Compliance professional to independently manage significant GCP compliance activities across R&D and ensure inspection readiness.

You will lead quality-system improvements, coordinate audits, drive risk assessments, and support continuous improvement while collaborating with study teams and cross-functional stakeholders. The role requires six years in pharma or CRO and strong regulatory knowledge.

Qualifications

• Bachelor’s degree or equivalent experience.
• Six years of experience in the pharmaceutical industry or CRO.
• Solid knowledge of clinical trial management and GCP compliance processes.
• Knowledge of regulatory requirements governing clinical trials and industry best practices.
• Advanced knowledge of drug development and clinical trial processes.
• Experience with clinical development training and process management methods and tools.
• Strong planning, execution, problem-solving, negotiation, collaboration, and communication skills.
• Experience working with stakeholders and teams using digital tools and project management 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 and R&D stakeholders.
• Lead quality-event investigations and corrective actions with root-cause analysis and risk escalation.
• Coordinate audit and inspection readiness through document review, requests, and post-inspection remediation.
• Analyze compliance metrics and trends to identify risks and prepare governance reports.
• Lead defined projects and workstreams with Clinical Trial Delivery and other functions.
• Translate audit/inspection lessons into practical, sustainable improvements.

Skills

Quality systems

GCP compliance

Regulatory knowledge

Project management

Stakeholder collaboration

Communication skills

Education

Bachelor’s degree

Tools

MS Office

Job description

Takeda Pharmaceutical Co. in Warsaw, Poland, seeks a Quality & Compliance professional to independently manage significant GCP compliance activities across R&D and ensure inspection readiness.

You will lead quality-system improvements, coordinate audits, drive risk assessments, and support continuous improvement while collaborating with study teams and cross-functional stakeholders. The role requires six years in pharma or CRO and strong regulatory knowledge.