Site Quality And Compliance Lead

Greenkey Resources LLC; Ridgefield (CT); On-site; USD 120,000 - 160,000; Full time

Job summary

Greenkey Resources LLC in Ridgefield, CT is seeking a Site Quality and Compliance Lead to oversee clinical trial quality and regulatory compliance across programs, including national and international studies.

You will drive inspection readiness, develop training, coordinate corrective actions, and report quality metrics while partnering with cross-functional teams and external stakeholders to raise the standard of clinical operations.

Qualifications

• Bachelor’s degree in life sciences required.
• 8+ years 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.
• Experience 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.

Responsibilities

• 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.

Skills

Quality management

Regulatory knowledge

Project management

Training development

Education

Bachelor’s degree in life sciences

Job description

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.