Clinical Compliance Manager

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Compliance Manager – Make an Impact at the Forefront of Innovation At Thermo Fisher Scientific, we're looking for an experienced Clinical Compliance Manager to help drive quality, regulatory compliance, and continuous improvement across our clinical research operations. In this role, you will serve as a trusted GxP expert, partnering with cross-functional teams and clients to ensure our systems, processes, and clinical programs meet the highest quality standards and comply with global regulatory requirements. As a strategic quality leader, you will identify risks, implement effective solutions, support regulatory inspections and audits, and help foster a culture of quality and compliance throughout the organization. What You'll Do Develops and executes quality and compliance strategies and initiatives across the organization, promoting awareness of quality and regulatory compliance standards, industry trends, and best practices. Conducts complex internal and external audits and inspections to ensure compliance with established quality assurance processes, global regulatory requirements, and client contractual obligations. Performs technical document reviews and other GxP quality activities in support of clinical development programs. Oversees governance and compliance management processes, develops and maintains quality guidance, reference materials, and compliance tools, and serves as a trusted expert to advance the department's quality vision and objectives. Lead quality and compliance initiatives to ensure clinical processes are executed in accordance with GxP regulations, company standards, and client requirements. Serve as a subject matter expert on GxP regulations, providing guidance to business partners and supporting risk assessment and mitigation activities. Develop, maintain, and improve quality management system documentation, including policies, procedures, guidance documents, and training materials. Drive continuous improvement initiatives that strengthen quality systems and operational efficiency. Create and maintain tools, dashboards, and reports to monitor compliance activities and quality metrics. Collaborate across departments to promote best practices and build strong quality partnerships. Investigate quality issues and non-conformances, perform root cause analysis, and implement corrective and preventive actions. Lead or support internal audits, client audits, regulatory inspections, and investigative site audits. Mentor and coach junior auditors and quality professionals to support their professional development. Build strong relationships with internal stakeholders and designated client quality teams to ensure successful quality outcomes. What We're Looking For Bachelor's degree or an equivalent combination of education, training, and relevant experience. 8+ years of experience in clinical quality, regulatory compliance, clinical research, or a related field. Strong knowledge of GxP regulations and the end-to-end clinical trial process. Extensive experience with Quality Management Systems (QMS), SOPs, and regulatory inspections. Excellent verbal and written communication skills, including the ability to communicate scientific and technical information effectively. Demonstrated experience leading audits and mentoring or training team members. Strong analytical, problem-solving, risk assessment, and decision-making skills. Excellent organizational, prioritization, and project management abilities. Proven ability to build collaborative relationships and influence stakeholders across functions. Proficiency with Microsoft Office and quality management systems, with the ability to quickly learn new technologies. Flexibility to travel as business needs require. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global organization dedicated to enabling our customers to make the world healthier, cleaner, and safer. You'll collaborate with talented colleagues, contribute to meaningful scientific advancements, and have opportunities to grow your career in an environment that values innovation, integrity, and continuous learning. If you're passionate about clinical quality, regulatory excellence, and making a meaningful impact on global healthcare, we'd love to hear from you. Apply today and help us deliver tomorrow's breakthroughs.