Apply on Employer Site

Neurogene Inc. · 2 months ago

Clinical Quality Assurance Specialist

New York, NY

Full-time

Onsite

Mid, Senior Level

3+ years exp

Neurogene Inc. is dedicated to treating neurological diseases through innovative gene therapy approaches. The Clinical Quality Assurance Specialist will ensure GxP compliance and quality oversight for clinical operations, assist with audits, and support the filing of investigational new drug applications while fostering continuous process improvement.

Biotechnology

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

Qualification

Clinical Practices (GCP)FDA regulationsClinical trial managementQuality Review of documentationElectronic Data Capture (EDC)Audit programsOrganizational skillsCommunication skillsProblem solvingSelf-starter

Required

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

Working knowledge of Good Clinical Practices (GCP), FDA regulations and quality standards

Strong understanding of regulatory and ICH-GCP requirements

Experience with Quality Review of clinical trial documentation

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