Hiring: Director, Validation Company: Cabaletta Bio Location: Philadelphia, PA Job Posted Time: 2026-09-03 10:57:13 Employment Type: Contract / Remote Target Skills & Keywords : Digital Transformation, Quality Assurance, R, Regulatory Compliance, Vendor Management About the job 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. •Strong knowledge of laboratory operations supporting advanced therapies. Required Skills: •Validation Program Leadership •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. Qualifications: •Bachelor's degree in Engineering, Life Sciences, Computer Science, Pharmaceutical Sciences, or related discipline required. •Extensive Knowledge Of Equipment Qualification (IQ/OQ/PQ) Compensation: •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!