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hims & hers · 1 day ago

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

Gilbert, AZ

Full-time

Onsite

Director/Executive

10+ years exp

Hims & Hers is a leading health and wellness platform focused on redefining healthcare through personalized care. The Director of Operations will lead and optimize both sterile and non-sterile compounding operations, ensuring compliance and high-quality patient outcomes while managing a large team in a fast-paced environment.

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Responsibilities

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, 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

Qualification

CGMP compliance503A503B regulationsPharmaceutical compoundingTeam managementProcess improvementQuality remediationKPI developmentCollaborative skillsLeadership skillsProblem-solvingCommunication skills

Required

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