Director, Validation

Cabaletta Bio Inc.•Philadelphia, PA

2d•Hybrid

About The Position

The Director, Validation is 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. This role 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 Biologics License Application (BLA) submission and commercial launch. The Director will establish a sustainable, risk-based validation lifecycle aligned with regulatory expectations for advanced therapies and autologous cell therapy products. Working cross-functionally with Quality Assurance, Quality Control, Information Technology, Research & Development, Regulatory Affairs, and external vendors, this position will ensure validated laboratory systems generate reliable, attributable, and inspection-ready data throughout product development and commercialization.

Requirements

Bachelor's degree in Engineering, Life Sciences, Computer Science, Pharmaceutical Sciences, or related discipline required.
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.
Extensive knowledge of: 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, ICH Q10, FDA Data Integrity Guidance, EU GMP Annex 11, ALCOA+ principles, Validation lifecycle management, Laboratory automation, Analytical instrumentation.
Experience with: Flow cytometry platforms, Cell counting instruments, PCR and qPCR systems, Bioanalytical instrumentation, Laboratory information systems, Scientific software applications.

Nice To Haves

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

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.
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.
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.
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.
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.
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.
Review vendor qualification documentation.
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.