Top 1 Qa biotech Jobs in Philadelphia Pa

Director, Validation
Cabaletta Bio —Philadelphia, PA
- Computer Science
- Engineering
- 11+ years
- Health insurance
- Paid time off
7d

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Director, Validation

Cabaletta Bio
Philadelphia, PA

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Job Details

7 days ago

Benefits

Stock options
Health insurance
Paid time off

Qualifications

Data integrity assurance
FDA submissions
Biotechnology
Laboratory equipment performance testing and validation
Automation
Team leadership
Laboratory instrument validation
FDA 21 CFR Part 11
Flow cytometers
ICH Q9
Production validation processes
Bachelor's degree
Pharmaceutical company experience
ICH Q10
Biomedical regulatory compliance
Regulatory submissions
Laboratory information systems (LIS)
GMP for research safety and compliance
Cytometry
qPCR
Senior leadership

Full 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. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew.

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work®

Responsibilities Include

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.

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.

Vendor Management

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.

People Leadership

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.

Technical Expertise

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

How to Apply

Please click the link at the bottom of the posting to submit an application.

Benefits

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.

Apply Now

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qa biotech jobs in philadelphia pa

Director, Validation

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About the Position

Responsibilities Include

Validation Program Leadership

Equipment and Instrument Qualification

Computerized Systems Validation (CSV)

Inspection Readiness

Quality Systems

Cross-Functional Leadership

Vendor Management

People Leadership

Required Qualifications

Education

Experience

Technical Expertise

How to Apply

Benefits

Equal Opportunity Employer

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