Quality Manager

Responsibilities

• Create and maintain SOPs, Work Instructions, and guidance in compliance with ICH-GCP and federal/local regulations
• Conduct internal study reviews to ensure compliance with ICH-GCP and applicable regulations
• Prepare official reports detailing review activities, risk categorization, and proposed corrective actions
• Assist site operations in developing and tracking Corrective and Preventive Action (CAPA) plans
• Conduct quality reviews of external sites for M&A due diligence
• Participate in the integration of newly acquired sites into the network
• Attend external audits and provide updates to internal leadership
• Support the development and delivery of training materials for site employees
• Travel up to 30% domestically and/or internationally

Requirements

• 5+ years of experience in the clinical research industry
• Bachelor's degree or equivalent (Associates Degree with 5 years equivalent experience considered)
• Excellent knowledge of current federal and local regulations on clinical research and GCP
• Proficiency in MS Office
• Ability to travel up to 30% of the time
• Strong communication and organizational skills

Preferred Qualifications

• Certification by a professional clinical research organization

About the Company

Headlands Research is a leading network of advanced clinical trial sites dedicated to enhancing clinical trial delivery through cutting-edge technology and exceptional support services.