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Headlands Research · 3 months ago

Director, Clinical Quality Assurance

United States

Full-time

Remote

Lead/Staff, Director/Executive

5+ years exp

Headlands Research is a leading network of advanced clinical trial sites focused on enhancing clinical trial delivery. The Director of Clinical Quality Assurance will oversee quality and training functions, ensuring high-quality data and patient safety during trials while managing a team and developing quality assurance programs.

BiotechnologyHealth CareMedical

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

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

Qualification

Clinical trials experienceQuality oversightRegulatory standards knowledgeSOP authoringTeam leadershipAnalytical skillsTraining material developmentProfessionalismProblem-solving skillsCommunication skillsOrganizational skills