Clinical Compliance Manager

• Develop and execute quality and compliance strategies and initiatives across the organization
• Promote awareness of quality and regulatory compliance standards, industry trends, and best practices
• Lead quality and compliance initiatives ensuring clinical processes comply with GxP regulations, company standards, and client requirements
• Serve as a GxP subject matter expert and support risk assessment and mitigation activities
• Develop, maintain, and improve QMS documentation, policies, procedures, guidance documents, and training materials
• Drive continuous improvement initiatives to strengthen quality systems and operational efficiency
• Create and maintain compliance tools, dashboards, and quality metric reports
• Conduct complex internal and external audits and inspections
• Support regulatory inspections, client audits, and investigative site audits
• Perform technical document reviews and other GxP quality activities for clinical development programs
• Investigate quality issues and non-conformances, perform root cause analysis, and implement corrective and preventive actions
• Oversee governance and compliance management processes
• Collaborate across departments to promote best practices and build quality partnerships
• Mentor and coach junior auditors and quality professionals
• Build relationships with internal stakeholders and designated client quality teams

• 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

• Opportunities to grow your career
• Professional development through mentoring and coaching
• Collaboration with talented colleagues
• Meaningful scientific advancement work
• Environment valuing innovation, integrity, and continuous learning