Director of Operations, 503A/503B Non-Sterile Compounding

Hims & Hers-posted 3 months ago

Full-time • Senior

Gilbert, AZ

11-50 employees

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We are seeking an experienced and strategic Director of Compounding Operations to lead and optimize both sterile and non-sterile 503A and 503B pharmacy operations. The ideal candidate will have a proven background in pharmaceutical manufacturing or compounding within cGMP-regulated environments and a passion for delivering high-quality patient outcomes. You will oversee daily operational activities, manage a large and diverse team, and drive strategic initiatives in a fast-paced, entrepreneurial environment. This role carries direct accountability for the quality performance of compounding operations and requires close collaboration with pharmacists, pharmacy technicians, Quality, Technical Services, and Regulatory Affairs to ensure audit readiness, inspection success, and sustainable compliance improvements.

Oversee all day-to-day operations of high-volume sterile and non-sterile compounding within 503A and 503B 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 and 503B 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.

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.

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.

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

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Director of Operations, 503A/503B Non-Sterile Compounding

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