Director of Clinical Research Quality

Headlands Research, Inc.; United States; Remote; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Director of Quality to enhance clinical trial delivery. This pivotal role involves overseeing quality assurance programs, ensuring compliance with regulatory standards, and leading a team in a rapidly growing environment. The ideal candidate will thrive in a dynamic setting, demonstrating exceptional problem-solving and analytical skills while fostering a culture of quality and continuous improvement. If you're passionate about making a significant impact in the clinical trials industry, this opportunity is tailored for you.

Qualifications

• 5+ years managing quality in clinical trials, especially in multi-site settings.
• Strong knowledge of US regulatory standards and clinical trial guidelines.

Responsibilities

• Oversee quality assurance programs and ensure compliance with regulations.
• Develop and maintain KPIs to evaluate quality assurance effectiveness.

Skills

Analytical Skills

Problem-Solving Skills

Communication Skills

Organizational Skills

Team Leadership

Regulatory Knowledge

Education

Bachelor's Degree in Business or Health-related Field

Master’s Degree

Tools

Quality Management Systems

CTMS

Job description

Overview

At Headlands Research, we are dedicated to enhancing clinical trial delivery to our communities. 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 20+ clinical trial sites in the US and Canada and have rapid expansion plans.

The Role

As the Director of Quality at Headlands Research, you will play a pivotal role in upholding the organization's commitment to delivering superior data quality to our pharmaceutical partners while ensuring the safety of trial participants. Your responsibilities will encompass overseeing the development and enforcement of quality assurance programs, conducting inspections and audits, and maintaining compliance with GCP and regulatory standards across all operational aspects.

We are seeking someone with specific experience supporting and leading quality development programs within a multi-site or large organization. The ideal candidate thrives in the dynamic atmosphere of a rapidly-growing company, embracing the opportunity to influence process development while supporting sites and contributing to the company's expansion. Success in this position requires agility, collaboration and exceptional critical thinking and problem-solving abilities.

Responsibilities

• Provide strategic oversight and direction to the Quality Department, ensuring alignment with the organization's business strategy and industry standards. Establish clear objectives and foster a culture of quality, compliance, and continuous 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.
• Lead and supervise regular annual and monthly quality reviews to ensure ongoing quality assurance and improvement.
• 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.
• 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.

Qualifications

• Bachelor's Degree in business or a health-related field is a minimum requirement, with a master’s degree being preferred.
• Minimum of 5 years of experience in directly managing quality within the clinical trials industry (sponsor or site) is a requirement.
  • Must have previous experience doing so for multiple sites or a large organization.
• 3+ years of experience leading a team required
• Fundamental knowledge of US regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations)
• Experience with quality oversight in Canada preferred
• Prior experience creating site SOPs preferred
• Ability to travel with sometimes short notice required
• 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