Overview
2nd Shift Quality Inspector Jobs in Alsip, IL at BETTS PRECISION INC
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
The Director, Clinical QA, is responsible for interacting with a team of professionals with an overall objective to strategically direct Clinical QA activities that provide an independent assessment (IA) of activity specifically related to Neurogene’s GCP, GLP and PV regulated processes and programs. The individual in this role will have an in-depth understanding and knowledge of appropriate regulatory compliance and other applicable regulations and laws, procedures, and appropriate processes, which allows the individual to plan and conduct internal and external audits independently. This role will mentor and supervise direct and indirect reports, as required.
Responsible for assuring the quality of clinical systems, processes, and related activities.
Ensures clinical programs, including clinical trials, meet global regulatory and company requirements.
Manage and conduct both internal and external quality audits, while supporting a compliance culture and process improvement.
Implement and maintain a risk-based QA audit program to oversee pre-clinical (GLP), clinical (GCP and PV), and post-approval (PV) programs. Lead qualification, routine and for-cause audits of external service providers, including CROs, investigator sites, non-clinical labs, laboratory and data management vendors, and other vendors to assess the effectiveness of their GxP compliance and adherence to approved study protocols and contracts.
Conduct internal and external document reviews and audits, including regulatory application documentation, protocols, study reports, and Trial Master File documents.
Act as the liaison for Clinical trial-related activities, including clinical meeting representation and review of clinical procedures and procedural documents.
Lead inspection readiness activities related to company and vendor inspections by regulatory authorities.
Coordinates tracking of document requests and responses.
Bachelor’s degree in life science or equivalent experience gained by working in relevant area (clinical research setting, laboratory, etc.)
Minimum 10 years of experience, including GCP auditing experience of early phase and late phase clinical trials; CRO, Pharma or Biotech industry
Related certifications (ASQ, SQA, ISO) preferred
Thorough understanding of Good Clinical Practices and FDA Part 11 (electronic documentation)
Knowledge and experience of other GxPs (GLP, GMP, PV, GDP, GPP, etc.) preferred
Experience hosting sponsor audits and regulatory inspections highly preferred
Experience with audit programs for cell or gene therapy programs
Experience managing an audit team
Demonstrated success in business, functional and people management
Consistently demonstrates clear and concise written and verbal communication
Demonstrated ability to remain unbiased in a diverse working environment
Effective negotiation skills
High degree of flexibility and ability to adjust to changing priorities and unforeseen events
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.Show more
Title: 2nd Shift Quality Inspector
Company: BETTS PRECISION INC
Location: Alsip, IL
