Cellares
cell therapy manufacturing
Director,QualityCompliance
“Director, Quality Compliance at Cellares. Skills: Quality Compliance, GMP, Regulatory CMC. Manage and lead Quality Compliance group. Ensure implementation and maintenance of Quality Management System”
What You'll Achieve.
maximizing efficiency, effectiveness and compliance; accelerate access to life-saving cell therapies; meet total patient demand for cell therapies at global scale; accelerate drug development and scale out manufacturing; lower process failure rates; lower manufacturing costs; meet global patient demand
Industry & Context.
technical challenges; operational issues; gap assessments
on-site regulatory inspections
What They're Looking For.
Must Have
Bachelor’s degree or higher in a scientific or engineering discipline, 10+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, solid experience in Quality Systems and Regulatory CMC, 5+ years of leadership experience, demonstrated knowledge of relevant cGMP regulations, Excellent knowledge of the regulations for biologics, cell and gene therapy products, knowledge of current Good Manufacturing Practices (GMP), experience with on-site regulatory inspections is required, Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products, Quality by Design approaches, Hands-on experience with designing and implementing GMP Quality Systems, Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy, Demonstrated experience in preparing regulatory submissions and response to health authorities queries
What You'll Do.
Manage and lead Quality Compliance group
Ensure implementation and maintenance of Quality Management System
Direct compliance programs for cGMP areas
Promote Quality culture globally
Ensure adherence to Quality System
Support tech transfer of cell therapy products
Provide Quality direction for operational issues
Manage Document Management System & Data Integrity programs
Prepare and host Quality Management Reviews
and approve change controls
Contribute to CMC sections of regulatory filings
Lead site preparation for inspections
Host regulatory and customer inspections
Prepare and approve follow up activities
Manage and oversee self inspection and internal audit programs
Perform global Quality audits
Responsible for GMP Training program
Review and approve SOPs
Collaborate with functional area leads
Oversee and monitor Quality metrics
and manage staff performance
How You'll Work.
Team & Collaboration
collaborate with site stakeholders and functions; Collaborate with functional area leads
Communication Scope
Prepare and host periodic Quality Management Reviews; Provide Quality direction and strategy; Collaborative host of regulatory and customer inspections and audits; Prepare and approval of follow up activities
Process & Methodology
change controls, risk assessments, CAPAs, investigations, validation protocols, continuous improvement plans
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