Senti Bio is currently recruiting for a Manager, Quality Assurance, reporting to the Sr. Director, Head of Quality. This exciting role provides visibility and exposure to a wide range of focus areas including external GMP manufacturing and testing quality oversight, batch record review, Clinical and pre-clinical quality assurance (GCP and GLP compliance), building and continuous improvement of quality programs and systems and supplier management, all supporting development of Senti’s cutting edge Cell Therapy and gene circuit technology. The ideal candidate brings experience in an early-phase clinical environment, a passion for learning, excellent communication skills, a collaborative can-do mindset, and an agile hands-on approach.
Responsibilites
- Assemble and review lot disposition documentation including manufacturing batch records and QC test records.
- Serve as a quality partner for external manufacturing providers, including participating or leading Quality subteam meetings, joint project team meetings, and CAPA/deviation/change management.
- Collaborate effectively and maintain strong working relationships with a wide variety of stakeholders including Supply Chain, Regulatory Affairs, Legal, Pre-Clinical, Clinical, Tech Ops, Project Management and others to provide QA oversight, quality partnership, and to build Senti Quality Culture and a compliance mindset.
- Apply quality risk management principles and risk-based approaches to processes and systems, including the generation, coordination, and maintenance of risk assessments.
- Generate and revise Quality System and QA documentation and procedures
- Proactively lead and support continuous improvement initiatives.
- Report quality related performance metrics to Quality Management Review.
Qualifications
- Minimum 6+ years of relevant experience including pharmaceutical/biotechnology industry and Quality Assurance experience.
- BS/MS degree in Biology, Chemical Engineering, Chemistry or a related field.
- Excellent understanding of GxP requirements with focus on FDA and EMA
- Excellent verbal and written communication skills
- Experience in in the areas of Cell and Gene Therapy, Flow Cytometry, Quality Control, Clinical Quality Assurance, Supplier Quality Management or External Manufacturing Oversight a plus!
Salary and Benefits
- Compensation for this role includes base salary, annual target bonus and equity
- The base salary range for this role is $135,000 - $153,000. Starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parity
- Significant growth opportunity as the company expands
- Empathetic, supportive and collaborative colleagues and work environments
Top Skills
What We Do
Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. To accomplish this mission, we are building a synthetic biology platform that could enable us to program next-generation cell and gene therapies with what we refer to as “gene circuits”. These gene circuits, which are created from novel and proprietary combinations of DNA sequences, are intended to reprogram cells with biological logic to sense inputs, compute decisions and respond to their cellular environments. We are designing gene circuits to improve the “intelligence” of cell and gene therapies in order to enhance their therapeutic effectiveness against a broad range of diseases that conventional medicines do not readily address.
For more information, please visit the Senti Bio website at https://www.sentibio.com.
