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 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 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.

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 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.
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 required; master’s degree preferred
5+ years of experience being directly responsible for managing quality within the clinical trials industry (sponsor or site) required
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