hims & hers
Director of Operations, 503A/503B Non-Sterile Compounding
hims & hers, New Albany, Ohio, United States, 43054
Overview
Director of Operations, 503A/503B Non-Sterile Compounding Hims & Hers is seeking an experienced Director of Compounding Operations to lead and optimize both sterile and non-sterile 503A and 503B pharmacy operations. The ideal candidate has 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
and other applicable standards , FDA, DEA, and state pharmacy board regulations.
Establish operational discipline prioritizing 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 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 KPIs that measure operational health, quality outcomes, and regulatory compliance.
Partner with executive leadership on growth strategy, capacity planning, and expansion across 503A and 503B.
Identify and implement technology solutions to streamline workflows and increase automation where appropriate.
Entrepreneurial Innovation
Thrive in a dynamic, growth-oriented environment requiring agility and creative problem-solving.
Lead change management, piloting new initiatives and scaling successful innovations.
Collaborate cross-functionally with Product Development, Supply Chain, Quality, and Business teams to realize operational vision 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 in cGMP environments.
5+ years of leadership experience managing large teams (100+ preferred).
Deep knowledge of 503A and 503B regulations and sterile/non-sterile compounding practices.
Strong technical knowledge of non-sterile dosage form production processes (e.g., blending, compression, granulation; gummy manufacturing preferred).
Proven ability to scale operations in a high-growth, regulated environment.
Proven ability to collaborate with pharmacists and technicians to improve 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.
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
We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and belonging. If you’re excited about this role, we encourage you to apply—even if you’re not sure if your background is a perfect match.
Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with applicable fair chance laws. It is unlawful in certain states to require or administer a lie detector test as a condition of employment. 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, please contact accommodations@forhims.com.
Location & Application Sentiment Columbus, OH
#J-18808-Ljbffr
Director of Operations, 503A/503B Non-Sterile Compounding Hims & Hers is seeking an experienced Director of Compounding Operations to lead and optimize both sterile and non-sterile 503A and 503B pharmacy operations. The ideal candidate has 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
and other applicable standards , FDA, DEA, and state pharmacy board regulations.
Establish operational discipline prioritizing 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 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 KPIs that measure operational health, quality outcomes, and regulatory compliance.
Partner with executive leadership on growth strategy, capacity planning, and expansion across 503A and 503B.
Identify and implement technology solutions to streamline workflows and increase automation where appropriate.
Entrepreneurial Innovation
Thrive in a dynamic, growth-oriented environment requiring agility and creative problem-solving.
Lead change management, piloting new initiatives and scaling successful innovations.
Collaborate cross-functionally with Product Development, Supply Chain, Quality, and Business teams to realize operational vision 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 in cGMP environments.
5+ years of leadership experience managing large teams (100+ preferred).
Deep knowledge of 503A and 503B regulations and sterile/non-sterile compounding practices.
Strong technical knowledge of non-sterile dosage form production processes (e.g., blending, compression, granulation; gummy manufacturing preferred).
Proven ability to scale operations in a high-growth, regulated environment.
Proven ability to collaborate with pharmacists and technicians to improve 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.
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
We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and belonging. If you’re excited about this role, we encourage you to apply—even if you’re not sure if your background is a perfect match.
Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with applicable fair chance laws. It is unlawful in certain states to require or administer a lie detector test as a condition of employment. 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, please contact accommodations@forhims.com.
Location & Application Sentiment Columbus, OH
#J-18808-Ljbffr