Walker Cole International are searching for a Senior Manager, Quality Assurance to join a fast-growing biotechnology company based in East Coat USA. They are advancing their therapeutic research in cell and gene therapy, right from discovery to clinical stage.
Your responsibilities as Senior Manager, Quality Assurance will be to:
- Development and maintenance of quality systems and report its quality metrics
- Provide quality metrics for both contracts and GMP products
- Work alongside CMC team and other departments ensuring SOPs follow regulatory standards.
- Develop an electronic learning management program
- Perform cGMP training for company employees
- Assess products and developments process in projects.
- Record and review regulatory filings such as IND, etc.
The successful candidate for the Senior Manager, Quality Assurance will demonstrate the following:
- BS/BA in a scientific field and at least 5 years within the pharmaceutical/biotechnology industry
- Knowledge and experience working within cGMP environment, global regulations and FDA submissions
- Covered stages from early to late clinical phases for product development
- Strong analytical and problem solving skills
- Ability to work cross-collaboratively within departments and present a self-starter attitude
- Be able to adapt in a fast-paced and commercialised environment
- Demonstrates priorities of task within organizational skills
Quality | Quality Assurance | QA | GMP | Good Manufacturing Practice | cGMP | Systems | Cell and Gene Therapy | Clinical | CMC | SOP