Director, Validation

Valid8 Financial, Inc.; Philadelphia (Philadelphia County); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Cabaletta Bio seeks a Director of Validation to lead laboratory validation programs across qualification, computerized systems, and data integrity. You will shape strategy, governance, and lifecycle management for instruments, software, and automation to ensure readiness for FDA inspections and regulatory submissions.

The role requires senior leadership experience in biotech or pharma, hands-on validation expertise, and a track record of improving compliance while driving efficiency in a

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, Pharmaceutical Sciences, or related discipline.
• 12+ years within biotechnology, pharmaceutical, cell therapy, gene therapy, or biologics industries.
• Minimum 5 years leading validation organizations.
• 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.

Responsibilities

• 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.
• Lead validation for equipment (IQ/OQ/PQ) and for laboratory CSV (LIMS, ELN, instrument software).
• Develop inspection-ready validation documentation and support regulatory audits.
• Partner with IT and system owners to manage system lifecycle, upgrades, and periodic reviews.
• Mentor and develop a high-performing validation organization and drive a culture of quality.

Skills

Strategic leadership

Regulatory compliance

Cross-functional collaboration

Quality systems

GxP and FDA familiarity

Education

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

Tools

LIMS

ELN

Laboratory data systems

Job description

Director, Validation – Remote or Hybrid, Philadelphia, PA

Responsible for developing, implementing, and maintaining the laboratory validation program supporting Research, Translational Medicine, Manufacturing Sciences and Technology, Analytical Development, Process Development, and other laboratory functions. Provides strategic and operational leadership for qualification and validation of laboratory instruments, equipment, computerized systems, and supporting infrastructure to ensure compliance with FDA, EMA, ICH, and GxP requirements in preparation for BLA submission and commercial launch.

Primary Responsibilities

• 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:
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Requalification
• 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:
  • Computerized systems validation
  • Data integrity
• 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
  • 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, and 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.

Experience

• 12+ years 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.

Technical Expertise

• Equipment Qualification (IQ/OQ/PQ)
• Computerized Systems Validation
• Risk‑based Validation
• GAMP 5
• 21 CFR Parts 11, 210, 211, 600 series
• 21 CFR Part 58 (where applicable)
• ICH Q9 and Q10
• FDA Data Integrity Guidance
• EU GMP Annex 11
• Laboratory automation
• Analytical instrumentation

Hands‑on Experience With

• Flow cytometry platforms
• Cell counting instruments
• PCR and qPCR systems
• Bioanalytical instrumentation
• Laboratory information systems
• Scientific software applications

Knowledge of autologous cell therapy manufacturing and analytical workflows strongly preferred.

Equal Opportunity Employer Statement

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.