Sr. Director, Clinical and Pre Clinical Quality Assurance
Full-timeSeniorQuality AssuranceCell and Gene TherapiesUnknownBachelors
$240K - $310K/yr
Description
Sana Biotechnology is a company that believes in the potential of engineered cells as medicines and is composed of a team that wants to lead with the desire to work on novel ideas. Sana is developing cell and gene therapies in type 1 diabetes, autoimmune disease, and oncology. As a Senior Director, you'll report to the Chief Medical Officer. You will lead Quality projects and set Quality expectations for GLP- and GCP-regulated work to ensure compliance with applicable regulations and standards. The Senior Director of Quality (GLP/GCP) will be responsible for the strategic approach to Quality that is phase appropriate. You will design, prioritize, implement, monitor, and communicate Sana's GLP/GCP quality strategy and quality programs. Further, you will establish and translate Sana's quality strategy into operational policies and procedures and training to meet global regulatory, medical/health, and legislative standards. We are looking for the experience, knowledge, and leadership credibility to be effective across Sana in multiple capacities, thereby ensuring compliance with Quality standards and corporate-wide commitment to Quality principles.
Requirements
Bachelor's degree required, advanced degree in relevant scientific field is a plus. 8+ years of relevant experience within biotechnology or pharmaceutical industry; including in development of complex biologics (such as gene therapy, vaccines, monoclonal/conjugated antibodies, enzyme replacement therapies), and small molecules. Collaborate well with all functional groups that Quality interacts, including CMC Quality. Ability to adeptly prioritize key items among a myriad of quality-related activities. Thorough understanding of industry regulatory environment related to Quality Systems; ability to evaluate complex situations and to provide practical perspectives/options for evaluating regulatory, financial, or legal risks and mitigations especially where compliance guidelines are inadequate. Be highly effective having difficult conversations on a routine basis internally or externally with partners; must be able to preserve the relationship while confronting quality issues that create unacceptable risks for Sana. Is intellectually curious, innovative, creative, practical/flexible, and remain calm under challenging situations.
Sana Biotechnology
BIOTECHNOLOGY
Cell & Gene Therapies
LocationWA - Seattle
Open Jobs12
UnknownCell TherapyType 1 DiabetesCell and Gene Therapies
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