Quality Operations Manager – Contract

Job not on LinkedIn

🔥 3 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

⚙️ Operations

👻 Ghost score 10%

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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Evolution Research Group

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Evolution Research Group is a clinical research organization dedicated to advancing medical science through innovative clinical trials. Specializing in therapeutic areas such as psychiatry, neurology, pain management, addiction, and various chronic conditions, ERG collaborates with healthcare providers and advocacy organizations to ensure inclusivity and thorough patient recruitment. With a robust database of potential participants and expertise in early-phase trials, Evolution Research Group aims to transform healthcare by supporting the development of life-changing therapies.

📋 Description

• Support and, as applicable, implement quality operations initiatives supporting the company's quality management systems • Collaborate with Project Management, Regulatory, Monitoring, Information Technology/Clinical Systems, Data Management, Biostatistics/Programming, and other operational staff on study document review, data reporting, site management issues, CAPA management, issue resolution, and database build/testing • Review study documents, including protocols, informed consent form templates, study plans, CAPAs, and memo-to-files, for compliance with protocols, regulatory requirements, SOPs, and company and sponsor standards • Support Quality Operations newsletters and create quality metrics trackers • Support sponsor audits through preparation, interviews, presentations, document retrieval, audit calls/meetings, and audit finding responses • Prepare, perform, and support internal eTMF and functional-area system audits • Support contract compliance QA audits, including audit plans, document reviews, audit findings tables, and finding responses • Provide training and managerial oversight support to the Quality Operations Associate; maintain training matrices and personnel training files • Perform audits of clinical sites and clinical third-party vendors • Report to the VP of Quality Operations on audit preparation, conduct, and follow-up • Support FDA inspections, including readiness training, inspection attendance, subject matter expert interaction, document retrieval/review, and scribing • Research FDA guidance and regulatory correspondence; maintain regulatory guidance tracking and notify CRO personnel of updates • Support the company Quality Management Plan and quality deliverables, including SOPs, standard documents, work instructions, and training materials • Provide Quality Operations support to core study teams on quality issue escalation, remediation, and study document review • Facilitate and manage vendor audits and support vendor qualification/assessments

🎯 Requirements

• Bachelor's degree, preferably in a scientific/healthcare field • Minimum 5–7 years of experience in a related area • Knowledge of FDA regulatory requirements • Experience as a GCP-focused clinical QA Auditor preferred, or quality assurance experience via a clinical site, CRO, and/or sponsor • Familiarity with clinical research concepts, practices, and procedures • Strong writing, presentation, and communication skills • Strong organizational, interpersonal, and teamwork skills • Exceptional attention to detail • Ability to enter data accurately and experience working with Microsoft Office • Ability to handle multiple tasks simultaneously • Ability to work in a home environment and travel environment • Ability to travel as required by audit and inspection activities