Description
Company Background
The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. This transformative work is driven by our highly collaborative people who come together each day to bring us closer to achieving our mission. As an employee of Neurogene, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong sense of purpose.
Position Overview:
Prior to applying and to be considered, you must have the minimum requirements of experience listed in the bullet points directly below:
- Audit conduct and management
-
-
- Current Experience as an auditor – coordinating and conducting audit activities, audit agenda and/or report preparation, review of responses to audit findings
- Audited clinical sites, vendors, and/or other types of audits
- CAPA oversight experience
- Perform quality review of CAPA plans/responses (for acceptance)
- Tracking and/or management of CAPA actions (i.e., verification of evidence) thru closure
- Can perform quality review and provide guidance on external vendor investigations and CAPA actions
- Quality reviewer of GCP/clinical study documents (ex. protocol, study-specific plans, etc.)
- Experience with Electronic Data Capture (EDC) and Trial Master File (TMF) systems along with related study activities
- Previous working experience in quality/QA related roles with a sponsor organization
- New York, Houston, TX or Remote - Travel 25%
- Bachelor’s degree in life sciences (Biology, Chemistry, etc.) or equivalent discipline required.
Reporting to the Director, Clinical Quality Assurance, this position will assist in ensuring GxP (GCP Specifically) 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. The individual will have understanding and knowledge of appropriate regulations and guidelines as well as audit management and conduct in support of clinical trial processes. The selected individual will be a team player in a small company environment in this highly cross-functional role.
Requirements
Accountabilities and 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.
Minimum Requirements
- Bachelor’s degree in life sciences (Biology, Chemistry, etc.) or equivalent discipline required.
- Experience: At least 3-5 years of relevant experience in the biotech/pharmaceutical industry specifically in a related clinical quality role.
- Licenses or Certifications: Related certifications (ASQ, SQA, ISO) a plus
- Knowledge: Working knowledge of Good Clinical Practices (GCP), FDA regulations and quality standards. Working knowledge of clinical trial management and operations.
Skills:
- 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.
- Work Environment: Travel 25%