Site Quality And Compliance Lead

Site Quality and Compliance Lead Overview

• The Site Quality and Compliance Lead oversees quality and compliance for clinical trial operations, ensuring adherence to regulatory standards and company policies.
• This role involves planning, preparation, and monitoring of clinical programs across various trial phases, including national and international studies.
• Responsible for implementing quality activities, inspection readiness, and contributing to global functional quality initiatives.
• Develops and delivers training programs to enhance compliance and operational excellence within Clinical Development Operations (CDO).
• Collaborates with cross-functional teams to address findings from inspections and audits, ensuring corrective actions are implemented effectively.
• Proactively identifies areas for quality improvement and implements strategies to mitigate risks in clinical operations.
• Ensures dissemination of lessons learned and quality trends to enhance organizational performance and compliance.
• Maintains high ethical standards and professionalism to uphold the organization’s reputation in the pharmaceutical community.

Site Quality and Compliance Lead Key Responsibilities & Duties

• Drive quality and compliance in clinical trial planning, preparation, and monitoring across multiple phases and programs.
• Implement and oversee inspection readiness activities, ensuring adherence to regulatory standards and company policies.
• Develop and deliver training programs to enhance compliance and operational efficiency within Clinical Development Operations.
• Collaborate with cross-functional teams to address inspection findings and implement corrective actions effectively.
• Conduct quality reviews and provide insights to improve processes and compliance within clinical operations.
• Act as the primary contact for non-compliance issues, coordinating resolutions with Quality Medicine and other partners.
• Develop and execute risk mitigation strategies to address potential areas of concern in clinical operations.
• Ensure timely reporting of quality metrics to assess trends and compliance issues within the organization.
• Maintain strong partnerships with internal and external stakeholders to drive quality and compliance initiatives.

Site Quality and Compliance Lead Job Requirements

• Bachelor’s degree in life sciences or a related field is highly preferred.
• Minimum of 8 years of experience in clinical operations or quality management; 10 years preferred.
• Strong knowledge of FDA, ICH, GCP regulations, and pharmaceutical lifecycle processes.
• Proven expertise in project/program management and training development within clinical operations.
• Ability to collaborate effectively with cross-functional teams and external stakeholders.
• Demonstrated skills in quality orientation, business process excellence, and risk mitigation strategies.
• Experience in handling sponsor inspections, audits, and implementing corrective actions.
• Familiarity with training curriculum development and delivery for clinical operations roles.
• High ethical standards and professionalism in all business interactions.