Quality Assurance Specialist – Neurogene

Company Background
At Neurogene, we are working to provide medicines to improve the lives of neurologically impaired children and their families. We envision a world in which all families have access to genetic medicines, even if the disorder is exceedingly rare. For children, our goal is to enable them to have a healthier future. For families, we want to make their lives better by easing the challenges of caring for someone with a devastating neurological disorder. As an employee of Neurogene, you will be part of a culture helping to make this dream a reality, collaborating with people in a start-up environment, whose mission is to improve the lives of the patients we serve and make the world a better place.

Position Overview
Reporting to the Associate Director of Quality Assurance, this position will assist in ensuring GxP compliance and quality oversight for Neurogene’s manufacturing operations. This role will collaborate across the company and support the filing of multiple investigational new drug applications and be part of the transformative shift the company is making as we move from the pre-clinical stage to IND enabling studies and to accelerated clinical development. The selected individual will be a team player in a small company environment in this highly cross-functional role.

Accountabilities and Responsibilities

  • Review and approval of Quality System and cGMP documents including, but not limited to, SOPs, Batch records, protocols and specifications.
  • Review and approval of change controls, non-conformances, OOS, deviations, complaints and related items; ensure investigations are thoroughly investigated and resolved.
  • QA review of manufacturing and QC related records, resolution of all related issues and QA disposition of product batches.
  • QA review and disposition of raw materials, buffers and other components.
  • QA review of initial qualification, validations and re-validations for facilities, equipment and processes.
  • QA support of GMP training program; Responsible for training/mentoring new hires on quality system
  • Internal and external compliance auditing; follow-up of audit CAPAs.
  • Responsible for generation, inspection and release of labels.
  • Responsible for maintaining the company’s controlled documents in accordance with GxP requirements.
  • Manages relationships and provides oversight of GMP activities conducted by third parties.
  • Participates in Quality Council, tracks KPIs; Ensures escalation of quality issues to management as appropriate.
  • QA support of nonclinical development programs both internally and at third parties.
  • Assists in identifying and implementing process improvement opportunities to existing systems.
  • Work closely with cross functional teams to ensure all work is completed to high quality in a timely and scientifically rigorous manner.

Essential Details

  • Work Schedule – Full-time; days. The role will mostly involve standard working hours, but flexibility is required to attend meetings/calls and QA support of production activities.
  • Travel -b The role may include travel to meet vendors and attend conferences and meetings
  • Quality Responsibility
    • Development and maintenance of quality systems and GxP compliance for the business by ensuring that team members comply with processes, procedures, and instructions for all activities in which the team participates.
  • Job Scope
    • Works on complex problems where analysis of multiple factors and consideration of data must be interpreted for decisions to be made.
    • Must be able to utilize past experience and established industry practices to temper decisions under consideration.
    • Exercises judgment within a broad spectrum of situations which affect product, policy and procedures.
    • This is a supportive role within the company and will provide responsibility for Quality Assurance.
    • The role will involve working closely with the Quality Assurance team as well as operational teams across the company.
  • Leadership Responsibility
    • The role is to provide support the development and maintenance of quality systems and GxP compliance.
    • The role will involve working closely with the Quality Assurance team as well as operational teams across the company.

Minimum Requirements

  • Education
    • Bachelor’s degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field
  • Experience
    • At least 5 years of relevant experience in the biotech/pharmaceutical industry
  • Knowledge
    • Working knowledge of cGMP requirements for biologics manufacturing. Working knowledge of requirements for aseptic manufacturing.
    • Basic knowledge of cell biology, cell culture.
  • Skills
    • Ability to work collaboratively in matrix organizations and team.
    • Ability to interpret cGMP requirements.
    • 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.

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