Director, Validation

Cabaletta Bio; Philadelphia (Philadelphia County); On-site; USD 180,000 - 250,000; Full time

Benefits offered by this job

Stock option plans

Health & retirement, PTO

Job summary

Cabaletta Bio, a late-stage clinical biotechnology company, is seeking a senior leader to head validation for laboratory systems and equipment as it advances its autoimmune therapies. You will build and govern validation programs aligned with regulatory expectations, drive lifecycle management, and partner across QA, IT, and R&D to ensure data integrity and inspection readiness.

The role emphasizes leading a high-performing validation organization, contributing to regulatory submissions and

Qualifications

• Bachelor's degree required in relevant science/engineering field.
• 12+ years of experience in biopharma/pharmaceuticals/biologics.
• Minimum 5 years leading validation organizations.
• Experience supporting BLA/NDA or commercial biologics submissions.

Responsibilities

• Lead and oversee laboratory validation activities across equipment, systems, and processes.
• Establish governance and lifecycle management for validation activities.
• Ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+ data integrity, and GAMP5.
• Develop inspection-ready validation documentation for FDA inspections.
• Partner with Quality Assurance, Analytical Development, Process Development, and IT to drive validation programs.

Education

Bachelor's degree in Engineering, Life Sciences, Computer Science, Pharmaceutical Sciences, or related discipline

Job description

About the Position

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew.

• Develop and execute the strategic roadmap for laboratory validation supporting transition from clinical-stage development through BLA submission and commercial launch.
• Establish governance for laboratory validation activities across R&D organizations.
• Develop policies, procedures, standards, templates, and lifecycle management processes for validation activities.
• Build a scalable validation framework consistent with current regulatory expectations for computerized systems and laboratory equipment.
• Lead continuous improvement initiatives to enhance validation efficiency while maintaining regulatory compliance.

Equipment and Instrument Qualification

• Direct qualification activities for laboratory equipment and instrumentation, including:
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Requalification
  • Decommissioning
• Ensure qualification documentation is scientifically justified and risk-based.
• Define validation strategies based on intended use, product impact, patient safety, and data integrity risk.

Computerized Systems Validation (CSV)

• Lead validation of laboratory computerized systems including:
  • Laboratory Information Management Systems (LIMS)
  • Electronic Lab Notebooks (ELN)
  • Instrument software
  • Scientific applications
  • Laboratory data acquisition systems
• Ensure systems comply with:
  • 21 CFR Part 11
  • Annex 11
  • ALCOA+ data integrity principles
  • GAMP 5 guidance
• Partner with Information Technology and system owners to manage system lifecycle, upgrades, patches, and periodic review.

Inspection Readiness

• Develop inspection-ready validation documentation supporting FDA pre-license inspections and regulatory audits.
• Ensure validation packages are complete, traceable, scientifically defensible, and readily retrievable.
• Lead inspection readiness activities related to laboratory validation.
• Support regulatory inspections by serving as subject matter expert for:
  • Equipment qualification
  • Computerized systems validation
  • Data integrity
  • Validation lifecycle management
• Lead remediation activities arising from inspections or internal audits.

Quality Systems

• Ensure validation activities integrate effectively within the Quality Management System.
• Review and approve:
  • Validation Plans
  • User Requirements Specifications
  • Risk Assessments
  • Functional Specifications
  • IQ/OQ/PQ Protocols
  • Summary Reports
  • Traceability Matrices
  • Periodic Reviews
• Support change control assessments for validated systems.
• Ensure deviations are appropriately investigated and resolved.
• Monitor validation metrics and report program status to senior leadership.

Cross-Functional Leadership

• Partner closely with:
  • Quality Assurance / Quality Control
  • Analytical Development
  • Process Development
  • Translational Medicine
  • Manufacturing Sciences and Technology
  • Information Technology
  • External Contract Laboratories
• Provide validation expertise during laboratory expansion, technology transfers, implementation of new analytical platforms, and adoption of automation technologies.
• Evaluate validation impact of new laboratory technologies and digital transformation initiatives.
• Oversee validation deliverables from equipment manufacturers, software suppliers, and validation consultants.
• Ensure vendor documentation meets company quality standards and regulatory expectations.
• Manage external validation resources as needed.
• Build, mentor, and develop a high-performing validation organization.
• Establish goals, performance expectations, and professional development plans.
• Foster a culture emphasizing quality, scientific rigor, collaboration, and continuous improvement.

Required Qualifications

Education

• Bachelor's degree in Engineering, Life Sciences, Computer Science, Pharmaceutical Sciences, or related discipline required.

Experience

• 12+ years of experience within biotechnology, pharmaceutical, cell therapy, gene therapy, or biologics industries.
• Minimum 5 years leading validation organizations.
• Demonstrated experience supporting BLA, NDA, or commercial biologics submissions.
• Experience establishing validation programs in rapidly growing biotechnology organizations.
• Experience supporting FDA inspections with positive outcomes.
• Strong knowledge of laboratory operations supporting advanced therapies.

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.