VP, Quality & Regulatory Affairs - Cell Therapy

Tom Trese Networking LLC; Germantown (MD); On-site; USD 250,000 - 360,000; Full time

Job summary

Tom Trese Networking LLC seeks an experienced Vice President of Quality & Regulatory Affairs to lead QMS, regulatory strategy, and compliance for a clinical-stage biotechnology company developing cell-based therapies.

This executive will oversee QA, QC, regulatory submissions (INDs), FDA interactions, and partner with Clinical, CMC, and external partners to drive programs toward commercialization.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• Typically 15+ years of progressive experience in biotechnology or cell therapy leadership.
• Direct Quality and/or Regulatory leadership experience with cell therapy or complex biologics — required.
• Experience with IND programs and direct interaction with FDA.
• Strong GMP knowledge for clinical manufacturing; QA/QC leadership.
• Ability to operate in a small company with strategic and hands-on responsibilities.

Responsibilities

• Provide executive QA and QC leadership with a phase-appropriate QMS.
• Develop and execute US regulatory strategy; liaison with FDA and other regulators.
• Oversee CMC development, manufacturing changes, validations, and supply chain controls.
• Ensure GCP systems and vendor oversight for clinical development.
• Build and mentor the QA/QC/Regulatory organization; recruit as needed.
• Promote accountability, scientific rigor, collaboration, and practical risk management.

Skills

Quality leadership

Regulatory affairs

FDA interactions

Risk management

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

QMS experience

Job description

Tom Trese Networking LLC seeks an experienced Vice President of Quality & Regulatory Affairs to lead QMS, regulatory strategy, and compliance for a clinical-stage biotechnology company developing cell-based therapies.

This executive will oversee QA, QC, regulatory submissions (INDs), FDA interactions, and partner with Clinical, CMC, and external partners to drive programs toward commercialization.