Senior Manager, GCP Compliance Warsaw, Mazovia Category: Quality

Job description

Senior Manager, GCP Compliance Warsaw, Mazovia Apply Now Job ID R0192262 Category Quality Subcategory Quality Business Unit Research & Development Job Type Full time By 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. 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 Apply Now Share this job Facebook Xing LinkedIn Email Related content Learn more Frequently Asked Questions Learn more Healthcare for all Learn more How We Partner Learn more Innovators in Science Award Winners Learn more Luck is not a strategy Learn more Takeda Unveils Newly Renovated Cambridge Building Learn more Our Commitment to the Planet Learn more Our Products Learn more Our R&D Pipeline Learn more Patient Story: Rosie Learn more Putting Patients First Learn more Sustainable Value Report 2023 Learn more Takeda Global Headquarters Learn more Informiere dich über Stellenangebote Takedas Produktionsstandort Learn more Takeda in the US Learn more Takeda’s Global CSR Program Learn more The History of Takeda Learn more Values and Corporate Governance Learn more Takeda Manufacturing - 2021 Facilities of the Year Learn more Takeda Acquires Adaptate Therapeutics Learn more BioLife Plasma Services Learn more Biotech Site in Covington, GA Learn more Takeda’s Position on Climate Change Learn more Corporate Responsibility Learn more <li class="js-hub-item hub-content__item showing-by-filter showing-by-load" data-hub-read-time="" data-hub-origin="False" data-hub-title="Diversity, Equity and Inclusion" data-hub-meta-title="" data-hub-meta="" data-hub-url="jobs.takeda.com/" data-hub-isfallbackpage="False" data-hub-order="0" data-hub-link="https://www.takeda.com/corporate-responsibility/sustainable-value-report/people/diversity-equity--inclusion/" data-hub-image="https://tbcdn.talentbrew.com/company/1113/v3_0/img/content/rc_dei.png" data-hub-created-by="TMP created" data-hub-date-updated="02.26.2025 19:36:57" data-