💼 About This Role

You'll lead quality and regulatory affairs for a 503B compounding pharmacy, ensuring inspection-ready systems and scalable operations. Your impact will drive compliance and strategic growth across the organization. This role offers a unique opportunity to shape quality infrastructure in a rapidly growing company.

🎯 What You'll Do

• Build scalable quality blueprint for sterile and non-sterile operations
• Serve as primary liaison with regulatory authorities during inspections
• Develop quality talent and drive operational excellence across sites
• Standardize site practices and improve throughput reliability

📋 Requirements

• 10+ years of leadership in quality/regulatory within FDA-regulated pharma
• Deep knowledge of 503B federal and state regulations
• Proven ability to build high-performance teams in fast-growth environments
• Expertise in compounding operations and quality systems

✨ Nice to Have

• Experience with sterile manufacturing
• Background in 503A compounding
• Regulatory affairs certification

🎁 Benefits & Perks

• 💰 Competitive salary $145k-$150k with bonus
• 🏖️ Paid time off
• 🏥 Health insurance
• 📈 Bonus opportunity
• 🏢 Onsite role in Alachua, FL

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter screen· 30 min
2. 2Hiring manager interview· 45 min
3. 3Technical interview· 60 min

🚩 Heads Up

• Role requires deep technical expertise but lists extensive strategic leadership duties