Operational Quality Specialist
📍 Location: Madison, WI (On-Site)
📂 Category: Clinical
🆔 Job ID: 254008
🕘 Work Hours: Monday–Friday, 8:00 AM – 4:00 PM (flexible based on trial needs)
🏢 Type: Full-time, Office/Clinic-based
About the Company
As one of the largest Clinical Research Organizations (CROs) in the world, with four Early Phase Clinical Research Units (CRUs) across the UK and US, we partner with leading pharmaceutical, biotechnology, and medical device companies to conduct early-stage clinical trials. Our mission is to establish the safety, tolerability, and pharmacokinetics of new drugs through rigorous, high-quality research.
Role Overview
The Operational Quality Specialist ensures that all clinical study operations adhere to the highest quality standards and regulatory compliance (ICH/GCP, SOPs, and study protocols). This role combines leadership, quality management, and process improvement, supporting continuous enhancement of operational excellence across Clinical Research Units.
You’ll work directly with cross-functional teams, regulatory bodies, and clients, playing a key role in audit readiness, CAPA management, and quality assurance within a fast-paced, technology-driven clinical research environment.
Key Responsibilities
Ensure all practical aspects of clinical studies are conducted per GCP, GLP, GMP, and relevant regulatory guidelines.
Provide leadership, coaching, and training to study staff to maintain compliance and performance excellence.
Interpret regulatory requirements and develop practical, compliant solutions for process improvements.
Lead Failure Mode and Effects Analysis (FMEA) activities at the site.
Take ownership of quality review components for assigned clinical projects.
Compile and analyze quality metrics to identify trends and areas for improvement.
Support and participate in client quality reviews, audits, and inspections.
Draft and manage Corrective and Preventive Action (CAPA) reports, ensuring timely closure.
Collaborate cross-functionally with Clinical Pharmacology Services (CPS) and Quality Assurance teams.
Facilitate quality discussion forums to identify operational errors, share best practices, and drive improvements.
Lead process reviews and standardization initiatives across CRUs.
Perform QC checks, data reconciliation, and contribute to operational data analysis for efficiency enhancement.
Participate in continuous improvement activities and promote operational excellence.
Qualifications & Skills
✅ Minimum 4 years of CRO experience, preferably in Phase I clinical trials
✅ Strong understanding of Quality Assurance (QA) principles and GCP/GMP compliance
✅ Experience in generating quality metrics, conducting trend analysis, and managing CAPA reports
✅ Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook)
✅ Strong communication skills (written & verbal) and ability to interpret study protocols/SOPs
✅ Analytical mindset with attention to detail and ability to work under strict timelines
✅ Adaptability in a fast-paced, technology-based, and team-oriented environment
Work Environment
Fast-paced: strict adherence to protocols and time-sensitive operations
Dynamic: shifting priorities requiring on-the-spot adaptability
Collaborative: strong teamwork and interpersonal skills essential
Digital-first: data collected directly into electronic systems
Benefits
Regular, full-time or part-time employees (20+ hours/week) are eligible for:
🩺 Medical, Dental, Vision, Life Insurance
💼 Short-Term/Long-Term Disability (STD/LTD)
💰 401(k) Retirement Plan
🏖️ Paid Time Off (PTO)
🏆 Employee Recognition Awards
🤝 Employee Resource Groups (ERGs)
🔗 Learn more: [EEO & Accommodations Request Information] (Insert official link if available)
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