Director of Quality and Regulatory Affairs

Job Summary

Providing enterprise Quality and Regulatory governance for U.S. operations, the full-time remote Director of Quality and Regulatory Affairs will manage compliance with FDA regulations and oversee the Quality Management System while ensuring product quality and operational excellence across multiple facilities.

Key responsibilities

• Lead Quality and Regulatory governance for all U.S. facilities and projects under 21 CFR Parts 210 and 211
• Maintain the Quality Management System in compliance with FDA cGMP requirements and oversee deviations, investigations, and audits
• Serve as the primary point of contact for regulatory inspections and ensure continuous compliance and inspection readiness across facilities

Required qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or related scientific discipline
• Advanced degree preferred (MS, PharmD, or PhD)
• Minimum 10 years of progressive experience in pharmaceutical, biotechnology, or radiopharmaceutical manufacturing environments
• At least 5 years of quality leadership experience in a regulated healthcare manufacturing environment
• Proven technical knowledge of FDA cGMP regulations and demonstrated success in leading FDA inspections