Careers
Manager, Quality Assurance - MQA-418
Ambit Biosciences is engaged in the discovery and development of small-molecule kinase inhibitors for the treatment of cancer. With more than 500 distinct kinases identified and over 30 kinase inhibitors in clinical trials or FDA approved, this important class of proteins is a rich area for therapeutic drug development. Ambit currently has two compounds in early stage clinical development. We are seeking a talented Manager, Quality Assurance to join our Regulatory team.
The Manager, Quality Assurance responsibilities will include, but not limited to:
- Establishing quality assurance function within company to provide appropriate oversight to support research and development
- Managing creation, revision and control of SOPs and other controlled documents and tools to assure adherence to GLP, GMP and GCP regulations
- Managing internal and external audits of vendors and clinical sites
- Reviewing processes and systems to ensure compliance with study protocols, SOPs and applicable guidelines/regulations and local laws in relation to the conduct of clinical study research.
The successful candidate will have the following qualifications:
- BS degree in scientific or healthcare discipline
- Minimum of five (5) years pharmaceutical industry experience with at least four (4) years in Quality assurance
- Working knowledge of GCP, GMP and GLP regulations
- Ability to work both independently and within cross-functional project teams
- Experience with working in an electronic document management environment highly preferred