Director, Quality

Location
South San Francisco, California, United States
Posted
May 23, 2021
Ref
2128495862
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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.

Senti Bio is seeking a Director of Quality Assurance, reporting directly to the executive team, to be the internal quality assurance/compliance lead for early-stage development programs. This role will be essential to support manufacturing for first-in-human studies using our novel cell therapy candidates. Strong technical background and training is desired, and the candidate will be supported by internal staff and external consultants as needed. A successful applicant will have prior hands-on experience taking a novel cell therapy through IND and early clinical trials, setting up 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 early-stage gene modified cell therapy clinical trials.
    • Direct development, initiation and maintenance of all quality systems in support of the product(s).
    • 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 SentiBio 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 audit preparation, training, and serve as lead FDA liaison during audits.
    • Drive implementation 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.


Qualifications
    • 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.
    • 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


Salary and Benefits
    • 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 a leading gene circuit company designing gene circuits to create a new generation of "smarter medicines" and enhance the therapeutic effectiveness of cell and gene therapies against a broad range of diseases that are unaddressed by current standards of care. We are proud to count Leaps by Bayer, NEA, 8VC, Matrix Partners China, Mirae Asset Capital, Amgen Ventures, Intel Capital, Ridgeback Capital, Lux Capital, KB Investment, Pear VC, Smilegate Investment, Menlo Ventures, LifeSci Venture Partners, Alexandria Venture Investments, Allen & Company, LifeForce Capital, Omega Funds, Nest.Bio, Gaingels, Noveus Capital, and Goodman Capital among our investors. Senti Bio is based in South San Francisco, CA, USA.