QA/Regulatory Affairs Leader for cGMP Startup

Medicines for All Institute; Richmond (VA); On-site; USD 148,500 - 181,500; Full time

Job summary

A non-profit health organization in Richmond, Virginia, seeks a Head of Quality & Regulatory Affairs. This leadership role involves establishing the Quality Management System and leading compliance with regulatory standards at a new cGMP facility. The ideal candidate will have extensive experience in small molecule manufacturing and regulatory affairs. Salary starts at $165,000, and candidates should demonstrate leadership in mission-driven environments.

Qualifications

• 5+ years of experience in small molecule drug substance manufacturing.
• 7+ years of supervisory experience in Quality Management or Regulatory Affairs.
• In-depth knowledge of FDA 21 CFR Parts 210/211.

Responsibilities

• Develop and maintain Quality Management System in compliance with regulations.
• Lead internal and external audits, ensuring QMS compliance.
• Develop regulatory strategies for submissions and compliance reporting.

Skills

Quality Assurance

Regulatory Affairs

Leadership

Communication

Root Cause Analysis

Education

Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or related field

Tools

Quality Management System (QMS)

CAPA

Job description

A non-profit health organization in Richmond, Virginia, seeks a Head of Quality & Regulatory Affairs. This leadership role involves establishing the Quality Management System and leading compliance with regulatory standards at a new cGMP facility. The ideal candidate will have extensive experience in small molecule manufacturing and regulatory affairs. Salary starts at $165,000, and candidates should demonstrate leadership in mission-driven environments.