Director Of Clinical Quality Assurance

Green Key Resources LLC; Nutley (NJ); Hybrid; USD 150,000 - 230,000; Full time

Benefits offered by this job

Remote work flexibility

Occasional in-office presence

Job summary

Green Key Resources LLC seeks a Director of Clinical Quality Assurance to lead NA QA strategy and ensure compliance with global regulations. You will oversee audits of study sites, vendors, and processes, and manage sponsor inspections across neuroscience and oncology areas.

You will develop staff, collaborate with cross-functional teams, and manage data integrity controls while traveling ~15% for audits and inspections.

Qualifications

• Bachelor's degree in a relevant discipline; advanced degree preferred.
• Minimum 12 years of experience in clinical research, operations, or related fields.
• 5+ years of experience in Good Clinical Practice (GCP) auditing.
• Expertise in inspection management and compliance with international regulatory standards.
• Proficiency in data integrity controls and systems quality for clinical areas.
• Ability to travel approximately 15% for audits and inspections.

Responsibilities

• Conduct audits independently, ensuring adherence to clinical quality standards and regulatory requirements.
• Oversee Clinical Quality Assurance audits of study sites, vendors, documents, and internal processes.
• Facilitate sponsor inspections of global clinical facilities and study sites, ensuring compliance and readiness.
• Provide training and development opportunities for Clinical Quality Assurance staff to enhance their capabilities.
• Collaborate with cross-functional teams to implement quality management systems and maintain compliance.
• Ensure adherence to international regulatory standards and guidelines for clinical trials.
• Develop comprehensive reports and analyses based on audit findings and inspection outcomes.
• Travel as required to conduct audits and support inspection management activities.

Skills

GCP auditing

Audit management

Regulatory compliance

Data integrity

Analytical skills

Neuroscience

Oncology

Travel 15%

Education

Bachelor's degree

Advanced degree preferred

Job description

Director of Clinical Quality Assurance Overview

• The Director of Clinical Quality Assurance oversees the North America Clinical Quality Assurance strategy, ensuring compliance with global regulations and guidelines.
• Lead audit and inspection management, ensuring adherence to Good Clinical Practice (GCP) standards and organizational policies.
• Collaborate with cross-functional teams to enhance quality management systems and ensure regulatory compliance.
• Provide expertise in therapeutic areas such as neuroscience and oncology, translating protocol objectives into actionable quality activities.
• Develop and implement skill-building initiatives for Clinical Quality Assurance staff, adapting to evolving technologies.
• Support sponsor health authority inspections, ensuring readiness and compliance of clinical facilities and study sites.
• Maintain Quality's independence and authority while effectively collaborating with senior stakeholders in high-pressure situations.
• Offer remote work flexibility with occasional in-office presence for audits and critical inspection activities.

Director of Clinical Quality Assurance Key Responsibilities & Duties

• Conduct audits independently, ensuring adherence to clinical quality standards and regulatory requirements.
• Oversee Clinical Quality Assurance audits of study sites, vendors, documents, and internal processes.
• Facilitate sponsor inspections of global clinical facilities and study sites, ensuring compliance and readiness.
• Provide training and development opportunities for Clinical Quality Assurance staff to enhance their capabilities.
• Collaborate with cross-functional teams to implement quality management systems and maintain compliance.
• Ensure adherence to international regulatory standards and guidelines for clinical trials.
• Develop comprehensive reports and analyses based on audit findings and inspection outcomes.
• Travel as required to conduct audits and support inspection management activities.

Director of Clinical Quality Assurance Job Requirements

• Bachelor's degree in a relevant discipline; advanced degree preferred.
• Minimum 12 years of experience in clinical research, operations, or related fields.
• Strong knowledge of neuroscience and oncology therapeutic areas.
• 5+ years of experience in Good Clinical Practice (GCP) auditing.
• Expertise in inspection management and compliance with international regulatory standards.
• Proficiency in data integrity controls and systems quality for clinical areas.
• Ability to travel approximately 15% for audits and inspections.
• Strong analytical skills and ability to produce detailed audit reports.