Head of Quality

Cartesian Therapeutics is reimagining cell therapies with transformative technologies to bring a new generation of treatment options to patients with autoimmune diseases.

Position Summary

Seeking a Vice President, Head of Quality to provide enterprise-wide leadership of the company's Quality Assurance and Quality Control functions as the organization advances from late-stage clinical development through Phase 3, BLA submission and commercial launch. This role is accountable for ensuring products are manufactured, tested, released and distributed in full compliance with applicable regulatory requirements and internal standards, while establishing and maintaining a state of inspection and site readiness in preparation for future regulatory audit and commercial operations.

This leader will build, scale and steward a risk-based, phase appropriate Quality Management System (QMS) that enables science-based decision-making, operational excellence and continuous improvement. Serving as a key thought partner to Regulatory Affairs and Operations leadership, this individual will bring both enterprise-level strategic thinking and hands-on operational quality leadership, including active engagement in GMP decision-making and lot disposition.

The candidate will embrace a collaborative work environment, demonstrate comfort operating across both strategic and technical domains, and effectively manage multiple projects concurrently. This position is ideal for candidates with experience in GLP/cGMP/GCP environments, with knowledge of ICH guidelines and FDA compliance for investigational cell therapy products.

Key Responsibilities:

• Set and execute the Quality vision and strategy across Quality Assurance and Quality Control, aligned with business goals, BLA preparations, and regulatory requirements.
• Build, steward, and continuously evolve a risk-based, phase-appropriate Quality Management System (QMS) that enables science-based decision making, operational excellence, and continuous improvement.
• Provide executive oversight of GMP quality operations, including lot disposition, deviation management, CAPA systems, change control, document control and management review.
• Maintain a state of inspection and site readiness, leading preparation for regulatory inspections, audits, and pre-approval activities.
• Lead quality involvement in regulatory submissions, health authority interactions, and inspection responses, ensuring consistent, defensible quality positions.
• Oversee the auditing activities for all suppliers, contract CROs, CMOs, outside testing laboratories, and internal operations
• Establish governance and oversight across GxP compliance, with primary execution focus on GMP; provide informed oversight of GLP and GCP activities as applicable.
• Author, review, and/or approve SOPs/policies and technical reports with general guidance
• Lead investigations (deviations, IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with minimal guidance.
• Support qualification and validation activities for Manufacturing and Quality Control in collaboration with the senior Manufacturing, Quality Control, and Validation leaders
• Author/co-author trending reports and quality reviews to senior management on key performance indicators under Cartesian's QMS
• Oversee QC analytical and microbiology laboratories, ensuring method validation/verification, stability, environmental monitoring, sterility assurance (if applicable), and compliant data handling.
• Bring sufficient technical depth and SME-level engagement to actively participate in analytical, QC, and data-drive discussions, enabling effective decision-making and issue resolution.
• Ensure on time testing, OOS/OOT management, trend analysis, and scientific investigations with robust root cause and sustainable corrective actions.
• Maintain reference standards, sample management, and LIMS/lab systems compliance.
• Optimize cycle times while maintaining scientific rigor; steward fitforpurpose controls and phaseappropriate testing
• Establish and review quality metrics and KPIs, authoring and presenting quality trend reports and management reviews to leadership.
• Drive continuous improvement initiatives across QA and QC to support scalabilities, commercial operations and long-term compliance.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, or related field; advanced degree (MS/PhD, PharmD, or MBA) preferred.
• 15+ years progressive experience in GxP quality roles, including 8+ years in leadership; VP/Senior Director level experience overseeing both QA and QC
• Demonstrated success leading regulatory inspections (e.g., FDA, EMA/MHRA or other global authorities) and managing remediation of complex quality observations.
• Deep knowledge of QMS, ICH Q7/Q8/Q9/Q10, 21 CFR Parts 210/211/820, EU GMP, ISO 13485 (for med devices), data integrity and validation/CSV.
• Proven leadership in commercial and/or late-stage clinical manufacturing environments (drug substance/drug product, sterile/aseptic, biologics, small molecule, or med device/IVD)
• Preferred experience in cell therapy with familiarity of associated manufacturing, analytical and regulatory requirements.