Senior Director, Project Quality

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 12%

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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 QMS requirements • Lead required QMS reviews • Research, implement, and manage an electronic QMS (eQMS) solution for all sites • Support site heads and directors in establishing and maintaining quality compliance processes • Create and develop the Project Quality team, including 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, risk, regulatory compliance, and sponsor quality offerings • Guide SOP harmonization to ensure compliance with current regulatory standards and guidance • Report quality performance feedback, metrics, QIs, and CAPAs to site staff • Guide and follow up on QIs and CAPAs with operational staff • 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 responses and quality-related communications with sponsors, IRBs, and the FDA • Review and interpret audit, inspection, and complaint reports to maintain patient safety and data integrity • Lead operational meetings, share lessons learned and best practices, and report quality metrics and trends • Review and ensure site compliance with FDA guidance, SOPs, GxPs, and Flourish site standards • Create quality performance metrics and report organizational quality health and risks 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, 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, travel up to 30%, use a computer daily, and occasionally work evenings and weekends

🏖️ 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