Responsibilities
- Oversee all day-to-day operations of high-volume non-sterile compounding within 503A environments.
- Ensure full compliance with cGMP standards, USP <795>, <797>, <800>, FDA, DEA, and applicable state pharmacy board regulations.
- Establish operational discipline that prioritizes safety, quality, and data integrity across all compounding activities.
- Collaborate daily with pharmacists and pharmacy technicians to ensure compounding accuracy, efficiency, and adherence to procedures.
- Drive and own the remediation of quality or compliance gaps, ensuring corrective and preventive actions (CAPAs) are sustainable, measurable, and verifiable.
- Lead, develop, and mentor a high-performing, cross-functional team of 100+ staff including pharmacists, technicians, supervisors, and support personnel.
- Strengthen technical and compliance capability at all levels, developing personnel of varying experience into a disciplined, quality-driven workforce.
- Foster a culture of accountability, continuous improvement, and operational excellence.
- Promote a strong quality mindset through leadership visibility, coaching, and direct ownership of performance metrics.
- Improve yield performance and reduce batch rejections through proactive process monitoring and targeted remediation efforts.
- Drive continuous improvement initiatives to enhance efficiency, throughput, compliance, and service levels.
- Develop and implement key performance indicators (KPIs) that measure operational health, quality outcomes, and regulatory compliance.
- Partner with executive leadership on growth strategy, capacity planning, and expansion efforts across 503A compounding.
- Identify and implement technology solutions to streamline workflows, enhance data capture, and increase automation where appropriate.
- Thrive in a dynamic, growth-oriented environment that demands agility and creative problem-solving.
- Lead change management efforts, piloting new initiatives and scaling successful innovations.
- Collaborate cross-functionally with Product Development, Supply Chain, Quality, and Business teams to bring operational vision to life while safeguarding compliance.
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 of all levels in a compliance-driven setting.
- Deep knowledge of 503A and 503B pharmacy regulations and sterile/non-sterile compounding practices.
- 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.
- Proven ability to work collaboratively with pharmacists and pharmacy technicians to improve technical processes, compliance, and patient safety.
- Strong track record of leading quality remediation, audit/inspection preparation, and sustainable compliance improvements.
Nice to Have
- Advanced degree (MBA, PharmD, MS in Operations/Healthcare Management).
- Six Sigma, Lean, or other process improvement certifications.
- Experience in a start-up, high-growth healthcare, or wellness company.
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
Work Arrangement
Hybrid
Team
Team size: 100+. Structure: high-performing, cross-functional team of 100+ staff including pharmacists, technicians, supervisors, and support personnel
Additional Information
- We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging.
- If you need assistance or an accommodation due to a disability, please contact us at accommodations@forhims.com and describe the needed accommodation.
- Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability.
