Quality and Compliance Program Manager

Position Summary The Quality Program Manager is responsible for driving quality systems, audit readiness, and regulatory compliance across Paradigm. This role owns the execution of SOPs, Working Progress Guidelines (WPGs), training compliance, mock audits, and quality reporting, ensuring Paradigm maintains a high standard of GCP compliance while supporting operational efficiency and growth. This is a hands-on role requiring strong attention to detail, cross-functional collaboration, and the ability to translate regulatory requirements into practical, site-friendly processes. Key Responsibilities Quality Systems & Central Documentation • Maintain, update, and version-control SOPs and WPGs • Manage SOP review cycles and change documentation • Update and maintain Paradigm shared forms, templates, and source documents Audit Readiness & Quality Control • Conduct mock audits across Paradigm sites • Track findings and corrective actions • Support continuous audit readiness with QC across all studies and sites Training & Credential Management • Ensure PI CVs and staff training records are current and accurate • Coordinate training documentation with sites and BD • Support onboarding and ongoing GCP training efforts Industry Monitoring & Education • Monitor industry updates (ICH-GCP, FDA guidance, best practices) • Attend webinars and training • Develop internal training or updates based on new guidance Reporting & Communication • Provide regular quality status updates to leadership • Identify trends and potential risks across sites • Serve as a quality resource for site staff and leadership Experience & Qualifications Required • Bachelor’s degree or equivalent experience • Minimum 2 years of clinical research experience • Strong knowledge of ICH-GCP and FDA regulations • Experience with SOP development or quality programs • Excellent attention to detail and documentation skills • Strong communication and organizational skills • Ability to work independently and manage multiple priorities Preferred • Prior experience in quality, compliance, or audit roles • Experience supporting multiple sites • Experience conducting mock audits or internal reviews • Familiarity with CTMS systems (e.g., RealTime) • Experience developing or delivering training Key Competencies • Detail-oriented and process-driven • Pragmatic (can balance compliance with site realities) • Comfortable influencing without authority • Strong follow-through and accountability • Continuous improvement mindset • Technology fluency with the ability to leverage digital tools to improve quality systems and workflows • Creative communicator able to design engaging training and educational materials • Strong eye for professional document design and continuous improvement Pay: $65,000.00 - $80,000.00 per year Benefits: • 401(k) matching • Dental insurance • Health insurance • Life insurance • Paid time off • Vision insurance Experience: • Industry clinical Research : 2 years (Preferred) Willingness to travel: • 25% (Preferred) Work Location: Remote Apply tot his job