Senior Manager, GCP Compliance

Takeda Pharmaceutical Co.; Warszawa; In loco; PLN 267.000 - 368.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Quality systems

GCP compliance

Regulatory knowledge

Project management

Stakeholder collaboration

Communication skills

Formazione

Bachelor’s degree

Strumenti

MS Office

Descrizione del lavoro

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, elevate, 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

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives - including your own.

Takeda is an equal opportunity employer.