Director – Clinical Quality Assurance

The Company

At Headlands Research, we are building a best-in-class site network to improve the delivery of clinical trial options in the communities we serve.  We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding outreach and participation with a focus on participant diversity. Founded in 2018, our company is in high growth mode; we operate 21 clinical trial sites in the US and Canada and have rapid expansion plans.

The Role

The Director of Quality is tasked with ensuring that Headlands delivers consistent, high-quality data to our pharma partners as well as ensuring patient safety during the trial process. This individual will oversee quality and training functions for the organization including, but not limited to, the development and maintenance of quality assurance and training programs and policies, oversight of inspections and audits, quality diligence for acquired sites, and management of SOP’s and quality documents to ensure GCP and all regulatory guidelines are adhered to.

Direct Reports- 3-4

This individual should bring a strong background in the clinical trial industry with specific experience supporting and leading multi-site or large research organization quality  development programs. Candidates should appreciate the atmosphere of a growing company and the need to impact process development while supporting sites. Success in this position requires agility, collaboration and exceptional critical thinking and problem-solving abilities.

Duties

• 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