Quality & Regulatory Lead, Cell Therapy

Sora Resource Group; Germantown (MD); On-site; USD 350,000 - 520,000; Full time

Job summary

Sora Resource Group is assisting a clinical-stage biotechnology company in finding an executive Vice President of Quality & Regulatory Affairs. The role leads QA/QC, regulatory strategy, and a phase-appropriate QMS across clinical development, manufacturing, and external partners.

The ideal candidate will have 15+ years in biotech or pharma with direct leadership in quality and regulatory programs for cell/gene therapy or similar modalities, and experience interfacing with the FDA.

Qualifications

• Bachelor's degree in life sciences, engineering, pharmacy, or related discipline; advanced degree preferred.

Responsibilities

• Provide executive leadership for QA/QC programs and establish a phase-appropriate QMS.
• Lead regulatory strategy and interactions with FDA and other authorities; oversee IND submissions and information requests.
• Ensure compliance with GMP, GCP, GLP; manage CROs/CDMOs and vendor oversight.
• Support clinical development, manufacturing, and testing with robust quality controls and release decisions.
• Drive a risk-based culture and align Quality/Regulatory plans with company milestones.

Skills

Quality leadership

Regulatory leadership

FDA interactions

GMP/GCP/GLP knowledge

Quality systems

CRO/CDMO oversight

Risk management

Regulatory strategy

Decision making

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Sora Resource Group is assisting a clinical-stage biotechnology company in finding an executive Vice President of Quality & Regulatory Affairs. The role leads QA/QC, regulatory strategy, and a phase-appropriate QMS across clinical development, manufacturing, and external partners.

The ideal candidate will have 15+ years in biotech or pharma with direct leadership in quality and regulatory programs for cell/gene therapy or similar modalities, and experience interfacing with the FDA.