Director Of Operations, 503a/503b Non - sterile Compounding

Director Of Compounding Operations

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve.

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.

You Will:

Pharmacy Operations Leadership

• 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.

Team Management & Leadership

• 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.

Strategic Planning & Execution

• 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.

Entrepreneurial Innovation

• 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.

You Have:

• 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.

Preferred:

• 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.

Our Benefits (there are more but here are some highlights):

• 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

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [email protected] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability.

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