Senior Manager, Quality Control
South San Francisco, California
Quality Assurance /
Full-Time /
Hybrid
Senti Bio is currently recruiting for a Senior Manager of Quality Control, reporting to the Senior Director, Head of Quality. This individual contributor role will be the primary point of contact and SME for all Senti QC topics including but not limited to oversight of external Contract Test Labs (CTLs), building and continuous improvement of QC programs, management of stability studies, providing input for setting of product specifications, data analysis and trending, authoring and review of QC-related documents for regulatory submission, and reporting of metrics to senior leadership, all supporting development of Senti’s cutting edge cell therapy and gene circuit technology.
The ideal candidate brings broad QC experience in early- and late-phase clinical environment, Cell Therapy experience, excellent communication skills, a collaborative can-do mindset, and an agile hands-on approach.
Responsibilites
- Establish and maintain phase-appropriate QC programs and procedures, ensuring alignment with FDA and EMA regulatory expectations
- Oversees outsourced vendor testing, manage data generated by contract test labs
- Collaborate effectively with the internal Analytical Development team and external manufacturing partners and CTLs to support testing, troubleshooting, method transfer, method qualification, and investigations of OOT/OOS, deviations
- Own and perform QC data analytics, monitoring, trending and reporting for release and stability programs
- Participate in setting and revision of product and specifications
- Author and review IND-associated documentation including technical source documents
- Establish and maintain systems for QC data archiving and retention
- Use a risk-based and data-driven approach to compliance
- Proactively lead and support continuous improvement initiatives
- Report QC metrics and data trend analysis to Quality Management Review
- Works with IT to continually strengthen data integrity for QC data
- Provides QC technical support for external testing sites and inspections
- Supports Annual Product Quality Review (APQR) activities.
Qualifications
- Bachelor's degree in life science or related discipline
- At least 8+ years of Quality Control experience in biologic therapeutics including products in early-phase clinical development
- Experience with early clinical stage cell/gene therapy programs preferred
- Excellent verbal and written communication skills
- Strong interpersonal skills; able to deal effectively with a variety of internal and external personnel.
Salary and Benefits
- Compensation for this role includes base salary, annual target bonus and equity
- The base salary range for this role is $155,000-$175,000. 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
