Thank you for your interest in a career at Senti Biosciences. We are seeking individuals who are passionate about the future of genetic circuit therapeutics and have the energy and boldness to thrive and grow in a dynamic and fast entrepreneurial environment.
Senti Bio is seeking a talented candidate to support quality system implementation for non-clinical & clinical phases. A successful applicant will be able to independently drive tasks and projects, work collaboratively with cross functional teams, and play a role in building the quality culture of the company as it grows. The candidate should have a combination of work experience and knowledge of GxP and regulatory requirements. Prior cell therapy or large molecule experience is highly desirable.
· Manage document control lifecycle and support daily activities that includes but not limited to document numbering, routing for review/approval, filing, tracking, and monitor of periodic review process. Support authoring QMS SOPs, as needed.
· Manage implementation and monitoring of training curriculum for employees across the organization. Create training e-folders for employees and track and report training status as required.
· Provide quality training for new hires and support ongoing GxP training as needed.
· Implement and Monitor performance metrics and continuous improvements of internal quality processes.
· Manage contract service providers (CSPs) that includes but not limited to follow up on audit outcomes, update the tracking list of CSPs, plan for periodic routine audits, and audit planning.
· Compile, organize, and file documents (hard copy & e-copies).
· Support document review, as needed.
· Undergraduate or graduate degree in Biological or science major .
· 4-6 years of Quality Assurance experience within pharmaceutical and/or biotechnology company. Strong knowledge of GLP, GMP, and GCP is required.
· Strong understanding of Quality best practices, including familiarity with Quality System Regulations, GxPs and applicable ISO standards.
· Work experience with different computerized systems and software such as MS Office skills (Word, Excel, Power point), Google Drive, and eQMS.
· Demonstrate ability to work independently with scientific/technical personnel.
· Excellent interpersonal skills, including listening, writing, facilitations, attention to detail.
· Have excellent organizational skills, multitasking, and decisiveness.
· Ability to effectively collaborate in a dynamic environment.
Competitive compensation package and title commensurate with qualifications and experience in the South San Francisco Biotech market. Significant growth opportunity as the company expands.
Senti Bio is the next generation therapeutics company that designs gene circuits and programs cells for tremendous therapeutic value. Our mission is to engineer an entirely new class of medicine that will transform people’s lives by curing the most challenging diseases. We are proud to count NEA, 8VC, Amgen Ventures, Pear Ventures, Lux Capital, Menlo Ventures, Allen & Company, Nest.Bio, Omega Funds, Goodman Capital, and LifeForce Capital among their investors. Senti Bio is based in South San Francisco, CA, USA.