VP, Quality & Regulatory Affairs — Cell Therapy

Zaddy Solutions; Germantown (MD); On-site; USD 230,000 - 310,000; Full time

Job summary

Zaddy Solutions is seeking an experienced Vice President of Quality & Regulatory Affairs to lead the Quality and Regulatory functions for a clinical-stage biotechnology company developing cell-based therapies.

The VP will establish a phase-appropriate QMS, provide strategic regulatory leadership with FDA interactions, and ensure compliance across clinical development, manufacturing, testing, and external partners.

Qualifications

• Bachelor's degree in life sciences, engineering, pharmacy, or related discipline.
• Typically 15+ years of progressive experience in biotechnology/pharmaceutical development with significant leadership.
• Direct leadership in Quality and/or Regulatory functions for cell therapy or related advanced biologics.
• Experience with IND programs and direct interactions with FDA.
• Strong knowledge of Quality systems, including deviation management, CAPA, change control, supplier qualification, audits, and product disposition.

Responsibilities

• Provide executive QA/QC leadership and oversight.
• Establish and evolve a phase-appropriate QMS for clinical-stage development.
• Ensure GMP, GCP, GLP and FDA regulatory compliance.
• Lead IND submissions, FDA information requests, and regulatory strategies.
• Oversee vendor qualification, audits, and CRO/CDMO management.
• Build and mentor a high-performing Quality and Regulatory organization.

Education

Bachelor's degree in life sciences, engineering, pharmacy, or related discipline.

Advanced degree preferred

Tools

Quality Management System (QMS)

Job description

Zaddy Solutions is seeking an experienced Vice President of Quality & Regulatory Affairs to lead the Quality and Regulatory functions for a clinical-stage biotechnology company developing cell-based therapies.

The VP will establish a phase-appropriate QMS, provide strategic regulatory leadership with FDA interactions, and ensure compliance across clinical development, manufacturing, testing, and external partners.