Senior Director, Project Quality

Flourish Research

4d•Remote

About The Position

Flourish Research is a progressive and diversified clinical trial organization with strong capabilities across multiple research areas. They are committed to excellence, diversity, and inclusion, striving to provide the best care to everyone. Flourish Research is looking for motivated individuals to contribute to life-changing research and offers a comprehensive benefits package, a supportive work environment, and growth opportunities. This role is within the Operational Quality division.

Requirements

Master’s degree or equivalent.
Minimum 8 years’ experience with quality and compliance management in a clinical research environment.
Strong understanding of research activities and processes at research sites, either hospital or clinic setting.
Expert working knowledge of clinical research quality management system requirements.
Comprehensive knowledge of clinical research processes and research site conduct.
Collaborative and supportive team player with ability to lead cross-functional initiatives while fostering relationships between quality and operations.
Expert-level understanding of the quality management process, including issue identification, triage, RCA, and CAPA.
Expert working knowledge of GCP guidelines and regulations as well as requirements of regulatory documents and submissions to IRBs.
Expert in data compliance and the requirements, best practice and organization of a clinical research site.
Excellent leadership skills, including mentoring and training of staff members at all levels.
Excellent interpersonal skills, including assertiveness, persistence, flexibility, highly organized and detail oriented.
Proactive, flexible, and driven mindset, able to keep yourself and others on task.
Extremely organized with a high attention to detail.
Excellent oral and written communication skills.
Excellent computer skills to include Office365 products.
Strong problem solving, risk assessment and impact analysis abilities.
Ability to think independently and influence when appropriate.

Nice To Haves

Exceptions may apply to extraordinary candidates with clinical operations background and strong quality and compliance mindset.

Responsibilities

Build, implement, and manage a companywide QMS; create controlled documents to support and maintain the QMS and its requirements.
Initiate and lead required QMS reviews per the Flourish Quality Manual.
Research, implement, and manage an eQMS solution for all sites.
Support site heads/site directors to establish quality compliance and ensure maintenance of process.
Create a Project Quality team – determine needs, qualifications, requirements, training, and processes.
Lead/support Project Quality team in execution of quality management processes across all sites (quality management plans, risk and QI management, Quality Evaluations, etc.).
Collaborate with Process Quality on quality-related process improvements.
Provide support to the business on quality matters to ensure regulatory compliance and achievement of commercial objectives, including quality offerings to sponsors (e.g., QTLs, CTQ factors, quality agreements).
Provide guidance and insight on SOP harmonization initiative, ensuring compliance of SOPs with the latest regulatory standards and guidance.
Report regularly to site staff quality performance feedback, metrics, reported QIs and CAPAs.
Provide guidance and follow-up on QIs and CAPAs to operational staff.
Support Project Quality team in using eQMS for study quality management.
Collaborate with Support Services regarding quality related aspects of new site integration and vendor management.
Lead and prepare sites for sponsor audits and inspections. Support physicians and site leaders with response letters and quality management related communication with sponsors, IRBs and the FDA.
Review and interpret quality reports (audits, inspections, and complaints) and act as a resource to ensure patient safety and data integrity are maintained by site personnel.
Lead operational meetings to ensure lessons learned and best practices are shared across all sites and report on quality metrics and trends across all sites.
Review and ensure site compliance with FDA guidance, SOPs, GxPs and Flourish site standards.
Create metrics on quality performance and report to senior leadership on overall quality health of the organization, as well as potential areas of risk.
Additional duties as assigned by your manager.