Clinical Compliance Manager

🕒 6 days ago

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Develop and execute quality and compliance strategies and initiatives across the organization • Conduct complex internal and external audits and inspections • Perform technical document reviews and other GxP quality activities supporting clinical development programs • Oversee governance and compliance management processes • Develop and maintain quality guidance, reference materials, and compliance tools • Lead quality and compliance initiatives for clinical processes • Provide subject matter expertise on GxP regulations • Support risk assessment and mitigation activities • Develop, maintain, and improve quality management system documentation, policies, procedures, guidance documents, and training materials • Drive continuous improvement initiatives for quality systems and operational efficiency • Create and maintain tools, dashboards, and reports monitoring compliance activities and quality metrics • Collaborate across departments to promote best practices and build 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 • Build relationships with internal stakeholders and designated client quality teams

🎯 Requirements

• 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 communicating 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 • Ability to build collaborative relationships and influence stakeholders across functions • Proficiency with Microsoft Office and quality management systems, with ability to quickly learn new technologies • Flexibility to travel as business needs require

🏖️ Benefits

• Opportunities to grow your career • Professional development through mentoring and coaching • Collaboration with talented colleagues • Environment valuing innovation, integrity, and continuous learning • Reasonable accommodation for individuals with disabilities • Equal employment opportunity