Essential Duties and Responsibilities
- Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase gene therapy clinical programs
- Increase compliance awareness and promote a culture of quality throughout the company, with a focus on laboratory and manufacturing operations
- Collaborate with multiple functions to perform QA oversight and ensure quality-related activities are executed efficiently
- Write, review and revise standard operating procedures
- Provide training to laboratory and manufacturing staff on GLP/GMP regulations, best practices and internal requirements
- Review and approve product-related documentation, including raw material release, batch records, quality control test results and resolve discrepancies, as needed
- Perform in-phase inspections in support of GLP studies, write inspection reports and prepare QA statements
- Review and approve Certificates of Analysis and/or Certificates of Test
- Perform internal and external audits of GxP vendors; assist in the resolution of non-conformances, deviations and investigations.
- Track open observations and Corrective and Preventative Actions (CAPA) to closure.
- Assist with the analysis of trends and metrics to ensure continuous quality improvements.
- Interface with contract manufacturing/testing organizations and alliance partners to resolve quality-related issues with minimal supervision
- Other duties as assigned
- In-depth understanding of GLP and GMP (drugs and biologics) regulations, guidance documents, systems, processes and procedures
- Great attention to detail
- Strong interpersonal skills
- Strong prioritization, organizational and negotiating skills
- Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management
- Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines
- This position does not have supervisory responsibilities.