Our Medical Device client is seeking a skilled Clinical Quality Assurance Professional to join our Clinical Quality Assurance (CQA) team. This role involves global assessment of processes, operations, and compliance with Good Clinical Practice (GCP) regulatory requirements and controlled documents.
The position offers flexible work arrangements: on-site at our location in Flagstaff, Arizona, or hybrid or fully remote work from most locations within the United States, depending on role responsibilities and business needs.
Responsibilities
Assist in establishing and maintaining quality systems that comply with clinical regulations and standards, including developing and presenting quality metrics within Clinical.
Provide compliance guidance to Clinical Study Teams and Functional Groups throughout the clinical investigation life cycle.
Evaluate compliance of Sponsors, Investigators, Monitors, and Vendors with protocols, ICH GCP guidelines, and relevant regulations, including the documentation and reporting of generated data.
Plan, schedule, and oversee internal and external quality assurance audits of systems, procedures, and controls used in clinical trial design, conduct, and analysis. Document and review audit observations and responses; assess impacts and recommend improvement initiatives.
Support the qualification, selection, and management of Clinical vendors, assessing their compliance with systems supporting clinical activities.
Offer compliance guidance and leadership for regulated activities, including preparing for and coordinating inspections/audits by regulatory authorities. Conduct inspection readiness training for Clinical Study Teams.
Collaborate with Clinical Leadership and Functional Teams to troubleshoot issues.
Oversee compliance of computer systems used in clinical activities. Contribute to developing quality management system documentation related to computer systems/software usage.
Stay updated on industry and regulatory trends to inform business needs and advise leadership on potential regulatory impacts.
Qualifications
Bachelor's degree and at least 3 years of experience in Biotech, Medical Device, Pharmaceutical, or Healthcare industries.
Minimum 3 years of experience in clinical and/or quality system compliance and auditing.
Knowledge of Good Clinical Practices (GCP) and relevant regulations.
Familiarity with the clinical research lifecycle and Subject Data Protection regulations.
Working knowledge of inspection management.
Demonstrated project management and leadership skills.
Strong organizational skills, flexibility, and ability to manage multiple tasks.
Excellent verbal and written communication skills.
Willingness to travel up to 25% to meet business and project objectives.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Health Care Provider
Industries
Staffing and Recruiting
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