Compliance Manager

• Conduct complex internal and/or external audits for compliance with quality assurance processes, standards, global regulatory guidelines, and client contractual obligations
• Identify issues affecting the quality or integrity of clinical research programs
• Determine root causes of non-conformance and develop strategies to address issues
• Perform technical document reviews and other GxP activities supporting clinical development programs
• Provide audit reports to management
• Plan and deliver quality services for contracted quality assurance audits, internal site audits, laboratory audits, and file audits
• Lead process and quality improvement initiatives
• Develop compliance-management tracking tools and materials and analyze trends
• Mentor less experienced staff
• Serve as project lead for group projects
• Create 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, including at least 2 years in Clinical Quality, GCP Compliance, or related role
• Strong working knowledge of ICH E6(R2/R3), EMA/MHRA/FDA expectations
• Proven experience in CAPA, root cause analysis, and deviation management
• Ability to communicate complex compliance issues clearly and effectively
• Comfort working in a matrix organization and managing cross-functional customers
• Thorough knowledge of applicable GxP and appropriate regional regulations
• Extensive knowledge of the clinical trial process
• Excellent oral and written communication skills, including medical and scientific terminology
• Training/mentoring experience
• Strong attention to detail
• Problem-solving, risk assessment, and impact analysis abilities
• Strong leadership, organizational, and time management skills
• Strong digital literacy and ability to learn appropriate software
• Flexibility and adaptability
• Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
• Clinical quality systems experience such as Veeva Vault or TrackWise is a plus
• Veeva QMS experience is a plus
• An equivalency combining appropriate education, training, and/or directly related experience may be considered sufficient

• Global team environment
• Collaboration and development opportunities
• Scientific excellence-focused workplace