Quality Assurance Manager

This opportunity is for a Quality Assurance Manager to provide independent oversight of clinical trial activities, processes, and documentation. The role focuses on ensuring compliance with regulatory requirements, internal procedures, and quality standards while supporting continuous improvement across clinical operations.

This position operates in a fast-paced, collaborative environment and plays a key role in maintaining quality across internal teams, vendors, and clinical programs.

Job Type: Full-Time

Compensation: $85,000 - $175,000

• Maintain up-to-date knowledge of GxP regulations and communicate relevant updates to stakeholders
• Support implementation, maintenance, and oversight of the Quality Management System (QMS)
• Develop, review, and maintain SOPs and quality documentation in alignment with regulatory requirements
• Provide client-facing QA support, including development of quality documentation and compliance guidance
• Establish and maintain quality standards, controls, and performance parameters across clinical programs
• Ensure compliance with federal, state, local, and organizational regulations and policies
• Implement and support Clinical Quality Assurance plans aligned with GCP standards
• Lead and support audit and inspection readiness activities, including regulatory inspections
• Plan and conduct internal and external audits, including vendor qualification and oversight
• Oversee CAPA processes, including tracking, root cause analysis, and escalation of quality issues
• Analyze quality metrics and trends to identify risks and support continuous improvement
• Provide QA guidance to cross-functional teams and support interpretation of regulatory requirements
• Review clinical and regulatory documents such as protocols, study reports, and summaries
• Support development and delivery of training materials related to GCP and SOPs
• Collaborate with clinical teams to investigate deviations, temperature excursions, and product complaints
• Participate in QA budget planning and resource forecasting
• Develop and report GCP quality metrics across the organization
• Support additional projects and responsibilities as needed

• 4-7+ years of experience in quality assurance or a related field
• Supervisory experience is preferred
• Strong knowledge of GxP, ICH-GCP, and FDA regulations
• Experience working with Quality Management Systems (QMS)
• Highly organized with the ability to manage multiple priorities
• Proficiency with Microsoft Office tools (Outlook, Excel, PowerPoint, Word)
• Strong attention to detail and ability to maintain confidentiality
• Ability to exercise independent judgment and decision-making
• Excellent communication and cross-functional collaboration skills

• Bachelor’s degree in a scientific discipline is preferred
• Equivalent experience with a related degree may be considered
• Foreign degrees should be supported by a U.S. equivalency evaluation if applicable

• Compensation may vary based on experience and seniority level
• Bonus eligibility and benefits package are included
• Vaccination requirements may apply depending on client-specific guidelines