This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted. This role also requires EST hours to be worked. 

Position Summary:

The Clinical Study Quality Lead, Senior Manager, is responsible for quality assurance oversight and management of clinical trial operations to ensure that clinical studies are conducted in compliance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols, and internal policies and procedures. This role includes developing and executing study-level audit plans, identifying and communicating compliance risks, managing risk mitigation plans, monitoring quality issues and compliance metrics, overseeing investigations and CAPAs, and ensuring proactive inspection readiness.

Key Responsibilities:

• Serve as the Quality Lead for assigned clinical programs, providing GCP compliance interpretation, consultation, and support to maintain or improve research quality, ensuring subject safety and data integrity.

• Maintain current knowledge of industry trends, standards, and methodologies related to GCP.

• Collaborate cross-functionally with internal clinical teams, external CROs, vendors, and investigator sites to promote consistent quality across programs.

• Conduct QA reviews of protocols and participate in operational review boards to identify risks and develop mitigation strategies.

• Develop and execute risk-based audit plans, ensuring audits are completed as planned; review audit reports, evaluate responses, and oversee CAPA development.

• Manage and lead domestic and international audits of clinical investigators, ensuring compliance with ICH GCP, applicable regulations, and organizational standards.

• Lead quality issue investigations, root cause analyses, and CAPA development; support study teams in implementing corrective and preventive actions to ensure sustainable compliance.

• Contribute to continuous quality improvement initiatives.

• Engage proactively with study teams and functions to ensure inspection readiness.

• Provide support during regulatory agency inspections at sponsor facilities or investigator sites.

• Serve as a representative for GCP Quality Management System as assigned.

• Participate in SOP/work instruction reviews and revisions.

• Review and analyze key performance indicator data and trends to identify risks and recommend remedial or preventive actions.

• Contribute to process improvement initiatives as needed.

• Develop and maintain QA-to-QA relationships with GCP vendors in alignment with quality agreements and participate in applicable vendor oversight committees.

Required Qualifications:

• Bachelor’s degree in a scientific or allied health discipline.

• Typically requires 6 or more years of relevant experience, or an equivalent combination of education and experience.

• In-depth knowledge of ICH GCP (E6 R2 & R3) and applicable global regulations and guidance (e.g., FDA, EU, MHRA, etc.).

• Strong experience across all phases of clinical trial development.

• Expertise in event management processes including investigation, root cause analysis, CAPA development, and effectiveness checks.

• Ability to understand and translate customer needs into quality management solutions.

• Strong verbal and written communication skills for both internal and external stakeholders.

• Ability to work independently with minimal supervision while managing multiple priorities and deadlines.

• Proficiency in managing complex projects to successful completion.

• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Visio).

• Experience analyzing key performance indicators and compliance metrics.