Careers
Director, Quality Assurance (DQA-414)
Ambit Biosciences is a privately-held biopharmaceutical company 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 Biosciences has the technology, the expertise and the vision to succeed in the kinase space. We are seeking a talented Director, Quality Assurance with particular expertise in GCP.
Responsibilities:
The Director, Quality Assurance will be responsible for the strategic leadership and guidance of QA functions with a focus on GCP activities. Other key responsibilities will include, but are not limited to:
- Directing the creation, revision and control of SOPs and other controlled documents and tools to assure adherence to GLP, GMP and GCP regulations and guidelines.
- Managing 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.
- Ensuring all electronic files are in compliance with applicable regulatory requirements
- Managing external audits of vendors and clinical sites.
- Managing the professional development of Quality Assurance personnel
Requirements:
- BS degree in scientific or healthcare discipline.
- Minimum of 10 years Quality Assurance experience in the biotech/pharmaceutical industry experience with at least five (5) years in a QA management capacity.
- Strong and demonstrated working knowledge of Global GCP, GMP and GLP regulations
- Ability to work both independently and within cross-functional project teams.
- Need someone who is "hands on" with strong people skills
- Experience with working in an electronic document management environment highly preferred.