Full Job Description
📋 Description
• As Director of Operations for 503A Non-Sterile Compounding at Hims & Hers Health, Inc., you will lead and optimize high-volume pharmaceutical compounding operations in a regulated cGMP environment, directly impacting patient safety, product quality, and regulatory compliance for a fast-growing, publicly traded wellness platform.
• You will oversee daily operations of non-sterile compounding for a team of 100+ staff, ensuring adherence to USP <795>, <797>, <800>, FDA, DEA, and state pharmacy board regulations while driving operational discipline, quality mindset, and data integrity across all batch production activities.
• You will partner with pharmacists, technicians, Quality, Technical Services, and Regulatory Affairs to remediate compliance gaps, lead CAPA initiatives, and maintain audit readiness, while fostering a culture of accountability, continuous improvement, and operational excellence.
• You will develop and implement KPIs to measure throughput, yield, and compliance, lead capacity planning and technology adoption efforts, and collaborate with Product Development and Supply Chain to scale innovations without compromising regulatory standards.
• You will mentor and develop a cross-functional workforce, strengthen technical and compliance capabilities at all levels, and lead change management initiatives in a dynamic, entrepreneurial environment that values agility and innovation in healthcare manufacturing.
• You will gain strategic influence by reporting to executive leadership, shaping growth strategy for 503A operations, and building a legacy of quality-driven operational excellence in a mission-driven company committed to accessible, personalized health and wellness.
🎯 Requirements
• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Business Administration, Operations Management, or related field.
• 10+ years of progressive experience in pharmaceutical compounding or manufacturing operations with direct exposure to cGMP-regulated environments.
• 5+ years of leadership experience managing large teams (100+ preferred), with proven ability to develop personnel in compliance-driven settings.
• Deep knowledge of 503A and 503B pharmacy regulations and sterile/non-sterile compounding practices, including USP <795>, <797>, <800>, FDA, and DEA requirements.
• Strong, hands-on knowledge of technical non-sterile dosage form production processes, including blending, compression, granulation, and preferably gummy manufacturing.
• Demonstrated success in scaling operations in a high-growth, regulated environment.
🏖️ Benefits
• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats