VP, Quality & Regulatory Strategy for Cell Therapy

Clinical Dynamix, Inc.; Germantown (MD); On-site; USD 260,000 - 360,000; Full time

Job summary

Clinical Dynamix, Inc. seeks an experienced Vice President of Quality & Regulatory Affairs to lead QA/QC, compliance, and regulatory strategy for a cell therapy-focused biotechnology company in Germantown, MD.

The role requires hands-on leadership, strategic direction, and independent decision-making to ensure GMP/GCP/GLP compliance, manage FDA interactions, and drive quality systems from early development toward commercialization.

Qualifications

• Bachelor's degree in life sciences or related field.
• Significant leadership experience in biotech/pharma QA/Regulatory.
• Experience with cell therapy or advanced biologics preferred.
• Strong understanding of GMP, GCP, GLP requirements for clinical/manufacturing.
• Experience interacting with the FDA andIND submissions.

Responsibilities

• Provide executive leadership for QA and QC across clinical development, manufacturing, testing, and external partnerships.
• Establish and maintain a phase-appropriate QMS supporting clinical-stage programs.
• Lead regulatory strategy and oversight of INDs, submissions, and FDA interactions.
• Ensure compliance with GMP/GCP/GLP and internal quality standards.
• Maintain independent quality authority for product disposition and release.
• Build and mentor a high-performing QA/QC and regulatory team.

Skills

Quality leadership

Regulatory leadership

GMP knowledge

FDA interaction

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Clinical Dynamix, Inc. seeks an experienced Vice President of Quality & Regulatory Affairs to lead QA/QC, compliance, and regulatory strategy for a cell therapy-focused biotechnology company in Germantown, MD.

The role requires hands-on leadership, strategic direction, and independent decision-making to ensure GMP/GCP/GLP compliance, manage FDA interactions, and drive quality systems from early development toward commercialization.