Senior Manager, Quality Assurance

Thank you for your interest in a career at Senti Biosciences. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. We are passionate about 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 are unable to address.

At Senti, we find purpose and meaning knowing that our efforts have the potential to improve the lives of patients and their families with more effective and safer treatment options. With science as our foundation and empathy as our key guiding principle, colleagues become friends, managers become mentors, and with time, cancer becomes history.

Summary: Senti Bio is currently recruiting for a Senior Manager, Quality Assurance, reporting to the Sr. Director, Head of Quality. This exciting role provides great visibility and exposure to a wide range of focus areas including external manufacturing quality oversight, batch record review, Clinical and pre-clinical quality assurance (GCP and GLP compliance), IND-associated document authoring and review, building and continuous improvement of quality programs and systems, supplier quality management, and internal and vendor audits, all supporting development of Senti’s cutting edge Cell Therapy and gene circuit technology. The ideal candidate brings broad QA 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.

Responsibilities:

• Establish and maintain systems for GxP document archive/retention.
• 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.
• Proactively lead and support continuous improvement initiatives.
• Establish and maintain Quality Assurance Agreements (QAgs) with critical suppliers.
• Report quality system and supplier performance metrics to Quality Management Review.
• Perform QA review of manufacturing batch records and batch release packages, IND-related documents, as well as SOPs, protocols, and reports.
• Serve as a quality partner for external manufacturing providers, including leading QA to QA meetings, leading or overseeing audit activities, and CAPA/deviation/change management.
• Generate and maintain Quality Assurance procedures and programs, ensuring alignment with FDA and EMA regulatory expectations.
• Leverage a risk-based approach to compliance including generation, coordination and maintenance of risk assessments.

Qualifications:

• Excellent verbal and written communication skills
• Minimum 8+ 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
• Experience in in the areas of Clinical Quality Assurance, Supplier Quality Management, External Manufacturing Oversight, or Cell Therapy a plus!

Salary and Benefits:

• The base salary range for this role is $XXX-XXX. Starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parity
• Empathetic, supportive and collaborative colleagues and work environments
• Significant growth opportunity as the company expands
• Compensation for this role includes base salary, annual target bonus and equity

Senti Bio is a publicly traded (Nasdaq: SNTI) gene circuit company headquartered in South San Francisco. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases using novel and unprecedented approaches.

We are committed to an inclusive and diverse Senti Bio. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse Senti Team. We welcome people of different backgrounds, experiences, abilities and perspectives and are an equal opportunity employer.