Senior Director, Project Quality

PURPOSE: Main point of contact and subject matter expert for all project quality functions across all sites owned and operated by Flourish Research. This includes managing and overseeing the Flourish QMS, driving and delivering operational quality and improvement initiatives, managing the Project Quality team, consulting on quality, risk, and regulatory compliance, and monitoring project quality compliance.

ESSENTIAL JOB FUNCTIONS:

A. Build, implement, and manage a company-wide QMS; create controlled documents to support and maintain the QMS and its requirements.

B. Initiate and lead required QMS reviews per the Flourish Quality Manual.

C. Research, implement, and manage an eQMS solution for all sites.

D. Support site heads/site directors to establish quality compliance and ensure maintenance of processes.

E. Create a Project Quality team – determine needs, qualifications, requirements, training, and processes.

F. Lead/support Project Quality team in execution of quality management processes across all sites (quality management plans, risk and QI management, Quality Evaluations, etc.).

G. Collaborate with Process Quality on quality-related process improvements.

H. 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).

I. Provide guidance and insight on SOP harmonization initiative, ensuring compliance of SOPs with the latest regulatory standards and guidance.

J. Report regularly to site staff on quality performance feedback, metrics, reported QIs and CAPAs.

K. Provide guidance and follow-up on QIs and CAPAs to operational staff.

L. Support Project Quality team in using eQMS for study quality management.

M. Collaborate with Support Services regarding quality-related aspects of new site integration and vendor management.

N. 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.

O. 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.

P. 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.

Q. Review and ensure site compliance with FDA guidance, SOPs, GxPs, and Flourish site standards.

R. Create metrics on quality performance and report to senior leadership on overall quality health of the organization, as well as potential areas of risk.

S. Additional duties as assigned by your manager.

Requirements

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

A. Work is performed remotely.

B. Travel may be required up to 30%.

C. Daily computer use.

D. Occasional evening and weekend work schedules.

MINIMUM REQUIREMENTS:

Education: Master’s degree or equivalent.

Experience: 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; exceptions may apply to extraordinary candidates with clinical operations background and strong quality and compliance mindset.

Knowledge and Skills:

A. Expert working knowledge of clinical research quality management system requirements.

B. Comprehensive knowledge of clinical research processes and research site conduct.

C. Collaborative and supportive team player with ability to lead cross-functional initiatives while fostering relationships between quality and operations.

D. Expert-level understanding of the quality management process, including issue identification, triage, RCA, and CAPA.

E. Expert working knowledge of GCP guidelines and regulations as well as requirements of regulatory documents and submissions to IRBs.

F. Expert in data compliance and the requirements, best practice, and organization of a clinical research site.

G. Excellent leadership skills, including mentoring and training of staff members at all levels.

H. Excellent interpersonal skills, including assertiveness, persistence, flexibility, highly organized, and detail-oriented.

I. Proactive, flexible, and driven mindset, able to keep yourself and others on task.

J. Extremely organized with a high attention to detail.

K. Excellent oral and written communication skills.

L. Excellent computer skills to include Office365 products.

M. Strong problem-solving, risk assessment, and impact analysis abilities.

N. Ability to think independently and influence when appropriate.