Quality Manager

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Headlands Research

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2018

🏥 Healthcare

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $2.9M Venture Round on 2022-05

Healthcare • Healthcare Insurance • Pharmaceuticals

Headlands Research is a multinational integrated clinical trial site organization that focuses on large-volume recruitment and retention of diverse, inclusive populations through extensive site databases and physician partnerships. With over 5,000 clinical trials successfully completed and a dedicated team of clinical research professionals, Headlands Research is committed to advancing innovative medical therapies to improve lives in various therapeutic areas, including CNS, mental health, and vaccines.

📋 Description

• Create and maintain Standard Operating Procedures (SOPs), Work Instructions, and other network- and site-level guidance • Review and edit SOPs and work instructions for regulatory compliance and conformity to network SOPs • Support development and delivery of network and site-level training events • Conduct internal study reviews for compliance with ICH-GCP and applicable regulations • Prepare reports on study review activities, categorize findings by risk, and propose corrective actions • Work with operations teams to remediate issues and noncompliance and implement preventive actions • Participate in quality investigations • Assist site operations with developing, implementing, and tracking CAPA plans • Assess and report site risks to operations • Conduct and report quality reviews of external sites for M&A due diligence • Participate in integrating acquired sites into the network • Share best practices to maintain site inspection readiness • Attend external audits and update internal leadership • Track and assist required employee training • Support development and delivery of training materials for site employees • Help site directors assess employee performance against quality standards • Participate in continuing education opportunities • Travel up to 30% domestically and/or internationally

🎯 Requirements

• 5+ years of experience in the clinical research industry required • Certification by a professional clinical research organization preferred • Bachelor’s degree or equivalent required • Associate’s degree with 5 years of equivalent experience will be considered • Excellent knowledge of current federal and local clinical research regulations and GCP • Skills adaptable from other cGXP work environments • Comfortable traveling up to 30% domestically or internationally, including Canada • Extreme attention to detail • Ability to communicate and work effectively with a diverse team of professionals • Strong communication and organizational skills • Comfortable taking direction from a supervisor or working autonomously • Proficient computer skills and use of MS Office • Ability to build rapport with employees and external clients

🏖️ Benefits

• Equal Opportunity Employer • Reasonable accommodation in employment and the application process for individuals with disabilities • Continuing education opportunities to stay up to date on relevant quality initiatives, regulatory guidance, and industry best practices