Senior Director, Project Quality

🕒 August 27

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 21%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Flourish Research

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Pharmaceuticals

Flourish Research is a national, multi-site clinical trial network and site operator that runs paid clinical studies across the United States. It provides end-to-end clinical research solutions — from first-in-human and early in-patient Phase I studies through Phase II–IV trials — and partners with pharmaceutical sponsors and CROs to accelerate trial execution using wholly-owned sites, experienced investigators, recruitment technology, and access to diverse and underrepresented patient populations. The company operates dozens of clinic locations across many U. S. states, specializes in therapeutic areas including cardiometabolic, oncology, neuroscience, infectious disease and vaccines, and emphasizes patient-centric care, high retention, and regulatory-quality study delivery.

📋 Description

• Serve as the main point of contact and subject matter expert for project quality functions across all Flourish Research sites • Build, implement, and manage a companywide quality management system (QMS) • Create controlled documents supporting and maintaining the QMS • Lead required QMS reviews • Research, implement, and manage an eQMS solution for all sites • Support site heads and site directors in establishing and maintaining quality compliance processes • Create and develop the Project Quality team, including determining staffing needs, qualifications, training, and processes • Lead and support quality management processes across all sites, including quality management plans, risk and QI management, and Quality Evaluations • Collaborate with Process Quality on quality-related process improvements • Advise the business on quality, regulatory compliance, and sponsor quality offerings such as QTLs, CTQ factors, and quality agreements • Guide SOP harmonization and ensure SOP compliance with current regulatory standards and guidance • Report quality performance feedback, metrics, QIs, and CAPAs to site staff • Provide guidance and follow-up on QIs and CAPAs • Support eQMS use for study quality management • Collaborate on quality 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 communications to sponsors, IRBs, and the FDA • Review and interpret audits, inspections, and complaint reports to maintain patient safety and data integrity • Lead operational meetings to share lessons learned and best practices across sites • Report quality metrics and trends across all sites • Review and ensure site compliance with FDA guidance, SOPs, GxPs, and Flourish site standards • Create quality performance metrics and report organizational quality health and risk areas to senior leadership • Perform additional duties as assigned

🎯 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 • Ability to lead cross-functional initiatives while fostering relationships between quality and operations • Expert-level understanding of quality management processes, including issue identification, triage, RCA, and CAPA • Expert working knowledge of GCP guidelines and regulations and requirements of regulatory documents and submissions to IRBs • Expertise in data compliance and the requirements, best practices, and organization of a clinical research site • Leadership skills, including mentoring and training staff members at all levels • Excellent interpersonal, organizational, detail orientation, oral communication, and written communication skills • Proactive, flexible, and driven mindset • Excellent computer skills, including Office365 products • Strong problem-solving, risk assessment, and impact analysis abilities • Ability to think independently and influence when appropriate • Ability to work remotely • Ability to travel up to 30% • Ability to work occasional evening and weekend schedules

🏖️ Benefits

• Health, dental, and vision insurance plans • 401(k) with a 100% employer match on the first 4% of employee contributions • Tuition reimbursement • Parental leave • Employee referral program • Employee assistance program • Life insurance • Disability insurance • Generous PTO plan covering vacation, sick, personal days and 8 paid holidays • Supportive and collaborative work environment • Endless growth opportunities