Director of Operations, 503A/503B Non-Sterile Compounding
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Job Location:
Gilbert, AZ - USA
Yearly Salary:
USD 180000 - 195000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Department:
Job Summary
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 were making better health outcomes easier to achieve.
Hims & Hers is a public company traded on the NYSE under the ticker symbol HIMS. To learn more about the brand and offerings you can visit and . For information on the companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit the Role: 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. 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. Bachelors 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. 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 youre excited about this role we encourage you to applyeven if youre 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 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. Please do not send resumes to this email address. To learn more about how we collect use retain and disclose Personal Information please visit ourGlobal Candidate Privacy Statement. Required Experience: Director
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:
You Have:
Our Benefits (there are more but here are some highlights):
Key Skills
- Risk Management
- Negiotiation
- Operational management
- Smartsheets
- Strategic Planning
- Team Management
- Budgeting
- Leadership Experience
- Program Development
- Supervising Experience
- Financial Planning
About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
