Director of Quality Assurance
Northeast
Our client is a biotechnology leader in gene therapy research on the East coast with almost three decades of excellence. The group has a focus on novel gene/cell therapy products with indications oncology, neurology, and cardio. This position will offer exposure to cutting-edge viral vector gene therapies in a Discovery and Translational research environment, in collaboration with big pharma sponsor partners.
Responsibilities:
- Prepare and serve as program liaison for inspections and audits, and address audit reports following the inspections
- Conduct training sessions and assist in training personnel and documenting training sessions
- Manage and supervise QA unit, coordinate implementation, and management of the QA unit across all facilities
- Manage staff to conduct internal audits, validations/qualification plans and reports, and document control and records, training, and proficiency testing
- Perform qualification audits of subcontractors, external audits for Good Laboratory Practice materials, processes, and studies from outside sites
Qualifications:
- Master’s degree in life sciences and 7-10 years of experience in quality assurance
- Effective team management skills, workflow management & performance management skills
- Experience working in GLP/GMP environment and knowledge of GLP/GMP’s required
- Experience in cell and gene therapy
- Experience with Microsoft Word, Excel, and Access databases
