Overview
Director of Quality Assurance, Clinical Jobs in United States at SciPro
Title: Director of Quality Assurance, Clinical
Company: SciPro
Location: United States
Duties & Responsibilities:
Clinical Trial Compliance: Ensure project team remains compliant with national and international regulatory standards and guidance for medical devices.
Audit Management: Develop and prioritize audit management plans and strategies for ongoing clinical trials and GCP programs. Plan, coordinate, and conduct internal system audits and external site/vendor audits in accordance with GCP guidelines.
SOP Development: Participate in or lead the development of departmental standard operating procedures, work instructions, forms, and templates.
Audit Reporting: Report audit findings to management, recommend resolutions, and verify corrective actions.
Training: Conduct training for staff on GCP and inspection readiness.
Regulatory Inspection Support: Prepare for and host regulatory inspections.
Vendor Audits: Conduct initial and ongoing audits of clinical vendors such as CROs, imaging core labs, and central laboratories.
Issue Escalation: Identify and escalate site, vendor, and study-related issues to management.
Team Management: Recruit, train, and mentor Clinical Quality resources.
Must haves:
Bachelor’s degree in scientific field of study
10+ years supporting clinical research
2+ years managing clinical trials
5+ years in quality function
2+ years of people management
Medical Device Industry experience
Hosted Regulatory bodies
Travel domestically and internationally
