This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Environmental Conditions
Office
Join Us as a Clinical Compliance Manager - Make an Impact at the Forefront of Innovation
The Clinical Compliance Manager is responsible for the assessment, management, and reporting of different kinds of audits. Conduct complex internal and/or external audits to ensure compliance with established quality assurance processes, standards, integral regulatory guidelines, and/or client contractual obligations.
Identification of issues impacting the quality and/or integrity of clinical research programs, determination of root cause of non- conformance and development of strategies to address issues.
Upon request performance of technical document review and other GxP practice activities in support of clinical development programs.
Planning and delivery of quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects.



Leads process/quality improvement initiatives.
Develops tools and other materials for tracking compliance management activities and analyzes trends.
Mentors less experienced staff and serves as project lead for group projects. Creates formal networks with key contacts across the department
Bachelor's degree in life sciences, nursing, pharmacy, or related field.
~5+ years of clinical research experience, with at least 2 years in Clinical Quality, GCP Compliance, or related role.
~ Proven experience in CAPA, root cause analysis, and deviation management.
~ Demonstrated ability to communicate complex compliance issues clearly and effectively.
~ Prior experience with clinical quality systems (e.g., Veeva Vault, TrackWise, etc.) In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the r

📌 Regulatory Compliance Manager (España)
🏢 Thermo Fisher Scientific
📍 España