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 seeking a Director/Senior Director of Quality Assurance, reporting to the VP of Regulatory & Quality, to be the internal quality assurance/compliance lead for our development programs. This role will be essential to ensure Phase-appropriate compliance of product manufacturing and clinical evaluation of our novel cell therapy candidates. Strong technical background and training is desired, and the candidate will be supported by internal QA staff and external consultants as needed. A successful applicant will have prior hands-on experience taking a novel cell therapy through IND and into clinical trials, setting up and maintaining quality management systems, overseeing GMP manufacturing at in-house and outsourced settings, and be comfortable in a fast moving and nimble culture.Responsibilities:
- Draft, revise, and/or approve controlled documents needed to support partner / contractor relationships and QA management activities.
- Responsible for design and implementation of Senti Bio’s quality and compliance systems for in-house and contract manufacturing for gene modified cell therapy clinical trials.
- Responsible for oversight of the QA function, including Supplier Management, the internal audit program, Quality Systems, Document Control, Training, and QA Validation as well as GCP/GLP compliance.
- Direct development, initiation, and maintenance of all Quality Systems in support of the product(s) including the Quality Management Review.
- Represent QA on project teams and with contract manufacturers as required. Direct all aspects of quality support and strategy for the project team on the designated product(s).
- Review and approve partner/contractor GLP/GCP/GTP/GMP documentation on behalf of Senti Bio QA and Operations.
- Review batch documentation and make recommendations for dispositioning product lots. Oversee unexpected event investigations (OOS, deviations, non-conformance), change control, CAPA, label review/approval for manufacturing and testing operations.
- Actively monitor ongoing contractor-related research, manufacturing, quality control testing, and other activities. Provide feedback to stakeholders in a timely manner as per established Quality Agreements.
- Ensure the project team objectives and timelines are supported by quality deliverables; including but not limited to strategic planning, resource capabilities/allocation, budgeting, and tracking of risks and issues.
- Responsible for internal and external audit preparation, training, and serve as lead FDA/Regulated Authority liaison during audits.
- Drive implementation and maintenance of document control systems and promote adherence to company regulations, policies, SOPs, and guidelines. Identify and anticipate trends in quality issues, collaborate with leadership team to implement quality initiatives.
- Provide expertise in the interpretation of regulations and guidance relating to product development from a quality perspective.
- Manage, train, recruit, and direct all staff in stage appropriate GMP.
Salary and Benefits:
- Bachelor's degree in life science or related discipline.
- At least 10 years of Quality Assurance experience in FDA regulated industry, preferably, biologic therapeutics.
- Prior experience with IND and early clinical stage cell/gene therapy programs.
- Competence in FDA and international GMP requirements. Strong working knowledge of GCP beneficial.
- Excellent verbal and written communication skills; ability to lead Quality function as part of multi-faceted projects.
- Strong interpersonal skills; able to deal effectively with a variety of internal and external personnel. Experience with change management.
- Proficient in MS Office applications
- Base pay and stock options to be determined based on application qualifications with the aim of being competitive with similar roles in the area
- Significant growth opportunity as the company expands
- Empathetic, supportive and collaborative colleagues and work environment
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.