The Opportunity

What You’ll Do

• Lead and maintain FDA-compliant Quality Systems (21 CFR Parts 210, 211, 820, 11, and 4)
• Drive quality strategy, ensuring consistent production aligned with regulatory standards
• Oversee vendor qualification programs, including audits and evaluations
• Lead regulatory activities, including FDA/DEA interactions and field actions
• Manage and enhance stability programs, including coordination with external labs
• Provide quality oversight for contract packaging and outsourcing programs
• Lead responses to FDA inspections, audits, and customer inquiries
• Ensure labeling compliance and regulatory submissions (e.g., SPL, CARES Act reporting)
• Oversee change control, deviations, CAPAs, and batch record review/release
• Drive continuous improvement through regulatory intelligence and quality system enhancements
• Partner cross-functionally and across sites to strengthen quality processes

• Bachelor’s degree in a scientific field (or equivalent experience)
• 5+ years in pharmaceutical or medical device industry, with regulatory experience
• Proven experience with FDA regulations and Quality Systems development
• Leadership experience managing people and/or complex processes
• Experience supporting or leading FDA inspections and audits
• Strong knowledge of ICH guidelines, DEA regulations (preferred), and cGMP environments
• Exceptional communication, organization, and problem-solving skills
• A proactive, solutions-oriented mindset with a drive for continuous improvement

Why Safecor Health?

• Cares deeply about patients and each other
• Is committed to doing the right thing
• Strives for excellence in everything we do

Ready to Make an Impact?