Senior Director of Quality Control

Summary

Join Caribou Biosciences, a leading clinical-stage CRISPR genome-editing biopharmaceutical company, as their Senior Director of Quality Control (QC). This pivotal role will lead and expand the QC function, ensuring compliance and integrity of GMP products and materials. You will develop robust QC strategies, collaborate with internal and external teams, and drive validation strategies. The successful candidate will report to the Vice President of Technical Operations and play a key role in advancing Caribou's programs toward commercialization. This position offers a competitive compensation package, including salary, bonus, and equity, along with comprehensive benefits.

Requirements

• Bachelor’s degree (BS) or higher in a STEM field
• 15+ years of experience in Quality Control within the biopharmaceutical industry, including 5+ years managing QC laboratories
• Significant experience in analytical method validation (10+ years)
• Expertise in Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP) regulations
• Strong leadership, communication, and interpersonal skills, with a demonstrated ability to lead cross-functional teams
• Proven ability to thrive in a fast-paced, team-oriented environment with excellent organizational and prioritization skills
• Proficiency in identifying challenges, developing solutions, and implementing them effectively
• Knowledge of statistical methods and experience using statistical analysis software
• Hands-on experience implementing and managing LIMS systems
• Excellent organizational, prioritization and planning skills in a fast-paced team-oriented environment
• Ability to work independently on multiple projects internally and with external vendors
• Possess a sense of urgency; identify challenges and problems and take the initiative to identify solutions

Responsibilities

• Lead and execute QC strategy, managing the internal QC team and external testing partners
• Develop, review, and approve specifications for drug products and critical materials to ensure regulatory compliance
• Oversee stability programs and establish expiry dates for materials and products
• Collaborate with Quality Assurance (QA) to develop and maintain QC-related SOPs
• Review and approve QC test results, Certificates of Analysis, SOPs, deviations, change requests, and CAPAs
• Drive validation strategies for analytical methods across Caribou’s programs
• Represent QC in cross-functional meetings, contributing to program and operational decisions
• Implement and maintain a LIMS system to streamline QC data tracking and ensure data integrity
• Build and maintain robust data integrity practices company-wide

Preferred Qualifications

• Experience in QC for cell therapy products
• Familiarity with laboratory equipment and software qualification
• Expertise in flow cytometry and cell-based potency assay qualification
• Exceptional technical writing skills, including SOPs, protocols, and validation reports

Benefits

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $265,000 to $280,000- This represents the present low and high end of the Company’s pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance
• Generous paid vacation time, in addition to company-observed holidays and floating holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program