Senior / Project Quality Assurance Lead

Senior / Project Quality Assurance Lead

This role plays a pivotal part in ensuring the highest standards of quality across clinical research projects within a global, fast-paced environment. You will act as a key GCP subject matter expert, guiding project teams in maintaining compliance with international regulations and internal quality standards. The position is highly collaborative, working closely with cross-functional clinical, regulatory, and sponsor-facing teams to proactively identify risks and strengthen quality systems. You will lead investigations into quality issues, driving root cause analysis and the implementation of effective corrective and preventive actions. The role also involves supporting audits, inspections, and quality reviews across assigned clinical programs. With a strong focus on risk management and continuous improvement, you will help shape quality outcomes that directly impact study integrity and patient safety. This is a dynamic position suited for a quality professional who thrives in complex, regulated environments and enjoys influencing best practices across global teams.

Accountabilities:

• Serve as GCP subject matter expert, providing guidance to project teams to ensure compliance with study protocols, ICH-GCP guidelines, and global regulatory requirements.
• Lead and support quality issue management, including root cause analysis, deviation assessment, and development of effective CAPA plans.
• Conduct risk assessments and proactively identify quality risks, implementing mitigation strategies and control measures.
• Perform quality assurance reviews, trending analysis, and oversight of project-level quality metrics.
• Support and participate in sponsor audits, regulatory inspections, and investigator site audits as required.
• Collaborate with internal QA teams and sponsor counterparts to ensure alignment on quality standards and expectations.
• Provide consultation on quality management systems and support continuous improvement initiatives across clinical projects.

Requirements:

• Bachelor's degree in life sciences, pharmacy, health sciences, or related field (Master's preferred or equivalent experience).
• 5+ years of GCP experience, or 3+ years with a Master's degree, ideally within a CRO or pharmaceutical environment.
• Strong working knowledge of ICH-GCP guidelines, FDA regulations, EU directives, and UK clinical research requirements.
• Experience supporting or participating in regulatory inspections and clinical quality audits.
• Solid understanding of clinical drug development processes and quality management systems.
• Strong analytical and problem-solving skills with experience in root cause analysis and CAPA development.
• Excellent communication, influencing, and stakeholder management abilities across global teams.
• Ability to manage multiple priorities independently in a fast-paced, deadline-driven environment.
• Willingness to travel domestically and internationally as required (up to approximately 15%).

Benefits:

• Competitive annual salary ranging from $65,500 to $130,500 USD, based on experience, education, and internal equity.
• Comprehensive benefits package including medical, dental, vision, and additional health coverage (varies by location).
• Remote work flexibility within the United States (and select Canadian locations).
• Opportunities to work on global clinical research programs impacting patient outcomes.
• Professional development in a highly specialized regulatory and quality environment.
• Exposure to sponsor audits, global inspections, and cross-functional quality leadership initiatives.
• Inclusive and collaborative work culture focused on scientific innovation and continuous improvement.
• Travel opportunities for audits, inspections, and project support activities.