Director, Clinical Quality Assurance Remote, United States

Headlands Research, Inc.; Mississippi; Hybrid; USD 90,000 - 130,000; Full time

Job summary

A leading clinical trial organization is seeking a Director of Quality to ensure high-quality data delivery and patient safety. The role involves overseeing quality assurance programs, training, and compliance with industry regulations. Ideal candidates have 5+ years in clinical trials and strong leadership experience. The position may involve remote work and occasional travel.

Qualifications

• 5+ years’ experience in the clinical trials industry.
• 3+ years’ experience leading a team.
• Fundamental knowledge of US regulatory standards.

Responsibilities

• Oversee and direct the Quality Department.
• Communicate, train, and author SOPs.
• Develop and maintain KPIs for quality assurance.

Skills

Strong analytical skills

Proactive problem-solving

Strong written and verbal communication

Exceptional organizational skills

Ability to work in a remote setting

Education

Bachelor’s degree in business or health-related field

Master’s degree preferred

Job description

Overview

At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company operates 21 clinical trial sites in the US and Canada with 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 SOPs and quality documents to ensure GCP and all regulatory guidelines are adhered to.

In addition to strategic oversight, the Director will also serve as the Quality Leader for a group of sites. This includes hands-on support in quality reviews, audit/inspection preparation, and CAPA resolution, ensuring that sites are inspection-ready and quality standards are consistently met.

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.

Responsibilities

• 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 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.
• Develop, monitor, and maintain employee training related to quality (GCP, IATA, PHI, KnowB4, etc.).
• Develop, implement, and maintain an internal review monitoring system and schedule.
• Report on quality trends and metrics to aid in process improvement and risk management.
• Work with Regional Director of Operations, Quality Managers and Site Directors to ensure quality incidents are investigated, root cause analysis performed, and CAPA implemented and monitored for effectiveness.
• Partner with regional leaders and site teams to identify changes and opportunities for process improvement.
• Provide guidance, support, training and interpretation of regulations, guidelines, and policies.
• Support coordination of sponsor audits, regulatory inspections, and mock audits.
• Oversee documentation, reporting and closure of significant compliance and/or site review findings.
• Act 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.
• Facilitate New Hire Orientation and onboarding in collaboration with HR for quality-related functions in clinical operations.
• Develop and implement a mentorship program for new site employees to foster quality across the enterprise.
• Facilitate CTMS training in collaboration with the ESource team.

Qualifications

• Education – bachelor’s degree in business or a health-related field required; master’s degree preferred
• 5+ years’ experience in the 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 SOPs 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
• 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
• Ability to meet deadlines and maintain professionalism and integrity

Voluntary Self-Identification and EEO

Voluntary Self-Identification: For government reporting purposes, candidates may respond to the voluntary self-identification survey. Completion is optional and confidential. Information collected will be used in accordance with applicable laws and DO NOT affect hiring decisions.

Headlands Research is an equal employment opportunity employer. We do not discriminate on the basis of protected status. If applicable, disclosure of veteran status or disability is voluntary and will be kept confidential.

Public Burden Statement: This survey should take about 5 minutes to complete. OMB Control Number 1250-0005, Expires 04/30/2026.