Clinical Quality Assurance Specialist

Role Summary

Clinical Quality Assurance Specialist. Reporting to the Director, Clinical Quality Assurance, this position will assist in ensuring GxP compliance and quality oversight for Neurogene’s clinical operations. This role will collaborate across the company and support the filing of multiple investigational new drug applications as well as foster continuous process improvement and regulatory compliance.

Responsibilities

• Review and approval of clinical trial documents including protocols, study reports and Trial Master File documents for accuracy, consistency and completeness. Ensure compliance with regulation requirements and internal standards.
• Maintain detailed records of reviews performed including identified issues and corrective actions taken.
• Assist with audits of clinical trial processes, investigator sites and documentation.
• Assist in identifying and implementing process improvement to existing Quality System, processes, and procedures.
• Collaborate with cross-functional teams to resolve quality related issues.
• Ensures escalation of quality issues to management as appropriate.
• Develop and conduct training on quality assurance procedures, regulatory requirements and best practices for clinical operations and relevant functional area staff.
• Support and assist inspection readiness activities related to company and vendor inspections by regulatory authorities.
• Work closely with cross functional teams to ensure all work is completed to high quality in a timely and scientifically rigorous manner.
• Other duties as required.

Qualifications

• Bachelor’s degree in life sciences (Biology, Chemistry, etc.) or equivalent experience gained by working in relevant areas (clinical research, laboratory, etc.)
• At least 3-5 years of relevant experience in the biotech/pharmaceutical industry specifically in a related clinical quality role.
• Related certifications (ASQ, SQA, ISO) a plus
• Working knowledge of Good Clinical Practices (GCP), FDA regulations and quality standards. Working knowledge of clinical trial management and operations.
• Strong understanding of regulatory and ICH-GCP requirements.
• Experience with Quality Review of clinical trial documentation
• Experience with Electronic Data Capture (EDC) and Clinical Trial Management systems along with Trial Master Files (TMFs) preferred.
• Experience with audit programs and regulatory authority inspections.
• Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
• Excellent communication (verbal and written) skills required.
• Problem solving skills and ability to make quality decisions based on technical facts and sound risk assessments is required.
• Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
• Ability to track and measure performance against defined metrics.
• Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
• Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.