Associate Director of Quality Control

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

Caribou is seeking an experienced and innovative Associate Director, Quality Control (QC), to lead key aspects of our QC strategy and operations. Reporting to the VP of Quality, this individual contributor will oversee QC testing and data management programs, serve as a key interface with contract labs and manufacturing partners, and ensure compliance with global regulatory standards. While this is currently an individual contributor role, the ideal candidate will demonstrate strong leadership potential and the ability to grow into a people management role as the QC function expands. This hybrid position is based in Berkeley, CA, with an expectation of being on-site up to three days per week, with flexibility as needed.

Key Responsibilities

Specifications & Release

• Lead the development, review, and approval of raw material, in-process, and drug product specifications
• Generate, review and approve Certificates of Analysis (CoA) and Certificates of Test (CoT)
• Represent QC in Specification Review Committees and ensure alignment across functions

Testing & Partner Oversight

• Oversee QC testing conducted at internal and external labs (CDMOs, CTLs)
• Provide QC leadership for analytical tech transfers and method qualifications
• Ensure timely, phase-appropriate execution of QC activities in alignment with cGMP and project/business needs

Compliance & Regulatory Support

• Act as QC SME for regulatory filings, inspections, committees, and change control processes
• Lead, review and approve investigations (as they relate to QC testing: OOS, OOT, deviations, etc.) and associated CAPAs
• Support implementation and oversight of compliant electronic systems (e.g., LIMS, ELN)

Stability & Data Management

• Design and manage stability programs compliant with ICH guidelines
• Oversee retain/reserve sample and trending programs
• Analyze QC data trends to identify areas for continuous improvement

Collaboration & Communication

• Collaborate with cross-functional stakeholders including QA, QS, Regulatory, Manufacturing, Analytical & Process Development, and Supply Chain.
• Represent QC during regulatory inspections and external audits
• Present data and recommendations clearly to technical and non-technical audiences

Team Growth & Leadership Potential

• Demonstrate readiness to lead and develop a growing QC team in the future
• Contribute to organizational design discussions and workforce planning within the Quality function
• Support mentoring and onboarding of new team members as needed

Key Competencies

• Technical Expertise in cell therapy QC
• Cross-functional Project Leadership
• External Partner and Vendor Oversight
• Regulatory Intelligence and Compliance (FDA, EMA, ICH, Data Integrity)
• Data Analysis, Trending, control charting (LIMS, SPC, Excel, PwrPt., JMP or equiv).
• Scientific Rigor and Quality Mindset
• Optimization and Efficiency: 5S, Lean, and Kaizen
• Effective Written (incl. technical) and Verbal Communication (incl. presenting in person and virtual meetings)
• Leadership Potential and Talent Development

Required Qualifications

• BS in Life Sciences or related field with 10+ years QC/analytical experience in biologics, cell therapy, or gene therapy; or MS/PhD with 6+ years of relevant experience
• Deep experience in specification management, analytical method transfer, stability programs, and regulatory submission support
• Strong working knowledge of cGMPs, 21 CFR Part 11, and global regulatory requirements
• Dem