Director, Clinical Quality Assurance

September 24

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Headlands Research

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Healthcare Insurance • Pharmaceuticals • Science

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.

201 - 500 employees

Founded 2018

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

💰 $2.9M Venture Round on 2022-05

📋 Description

• Oversee and direct the Quality Department, ensuring its alignment with the broader business strategy and adherence to industry standards, while establishing clear goals and promoting a culture of quality, compliance, and ongoing improvement. • Communicate, train, and author (when applicable) Standard Operating Procedures (SOPs) including periodic review/revisions of procedures and policies to ensure compliance with regulations and guidelines in both the US and Canada. • Develop and maintain key performance indicators (KPIs) to evaluate the effectiveness of quality assurance activities and initiatives. • Conduct and/or oversee annual and monthly quality reviews. • Support the corporate development team through quality review of potential acquisition candidates. • Developing and monitoring employee training as applicable to quality, including GCP, IATA, PHI, KnowB4, etc. • Develop, implement, and maintain an internal review monitoring system and schedule. • Report out on quality trends and metrics to aide in effective process improvement and risk management. • Works with Regional Director of Operations, Quality Managers and Site Directors to ensure quality incidents are investigated, root cause analysis is performed, and a CAPA has been implemented and monitored for effectiveness. • Partners with regional leaders and site teams to identify potential changes and opportunities for process improvement. • Provide guidance, support, training and interpretation of regulations, guidelines, and policies • Supports coordination of sponsor audits, regulatory inspections, and mock audits. • Oversee documentation, reporting and closure of significant compliance and/or site review findings. • Acts as backup Quality Manager for all sites within the network. • Serve as the Quality Leader for assigned sites, providing direct hands-on support with quality reviews, audits/inspections, and CAPA resolution to reinforce site-level compliance and readiness. • Facilitates New Hire Orientation and on boarding in collaboration with HR for clinical operations to specific functions related to quality. • Develops and implements a mentorship program for new site employees to foster quality across the enterprise. • Facilitates CTMS training in collaboration with ESource team.

🎯 Requirements

• Education - bachelors-degree in business or a health-related field required; master’s degree preferred • 5 years’ + experience in clinical trials industry (sponsor or site) with experience in managing quality • 3+ years’ experience leading a team • Experience with Quality oversight in Canada preferred but not required • Prior experience authoring site SOP’s preferred but not required • Fundamental knowledge of US regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations) • Ability to work in a remote setting with travel required sometimes with short notice • Demonstrates strong analytical and proactive problem-solving skills • Strong written and verbal communication skills • Exceptional organizational skills, ability to multi-task and be detail oriented • Experience developing and implementing training materials • Accomplishes work in accordance with scheduled objectives and effectively meets deadlines • Ability to maintain high degree of professionalism and integrity