Title: Quality Assurance/Compliance - Drug Product/API Subject Matter Expert
Location: Carlsbad, CA
Our client is a leading biotech, discovering and creating RNA-targeted therapeutics. They are looking for a Manager of Quality Assurance and Compliance to join their team in Carlsbad. The ideal candidate will have a diverse skill set with experience with API and drug manufacturing.
- Provide oversight for in-house or contracted manufacturing and testing activities for Drug Substances
- Failure analysis, problem solving, risk management for quality events or issues
- Review and approve technical reports
- Internal audits of in-house operations and external audits of vendors
- Create and implement enhancements to company Quality System policies and procedures
- Broad knowledge of drug development, at least 5 years of QA experience in a GMP environment
- Experience with internal and external audits with domestic AND international regulatory requirements (FDA, EMA, Health Canada, MHLW, and ICH)
- Experience performing lot disposition activities, reviewing technical and validation reports
- Prior use of electronic quality management systems
- Batch records and quality control data review
If you are interested in hearing more about this position, please do not hesitate to apply!