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Associate Director, Quality

Senti Biosciences

Senti Biosciences

Administration, Quality Assurance
South San Francisco, CA, USA
Posted on Friday, June 21, 2024
Senti Bio is currently recruiting for an Associate Director, Quality Assurance, reporting to the Sr. Director, Head of Quality. This individual contributor role supports the Head of Quality and the site as a QA partner and leader with a cross-functional and multi-disciplinary focus. The role’s scope includes Lot Disposition, supplier quality management, compliance, Quality Management Review, GCP QA, external manufacturing oversight and more, 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.

Responsibilites

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

Qualifications

  • Minimum 10+ 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 Clinical Quality Assurance, Supplier Quality Management, External Manufacturing Oversight, or Cell Therapy 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 $168,000-$195,000. 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